TAB_black

MSc Pharmaceutical Technology
and Quality Assurance

Division of Pharmacy and Optometry

Faculty of Biology, Medicine and Health

PROGRAMME HANDBOOK

2021/22

Table of Updates

Date of update	Update	Additional information
Feb 2022	Deadlines for Assessed Work, Mitigating Circumstances and Requests for interruptions: links to online application forms added; references to old application forms removed.
	Appendix 1, 2 and 3: deleted – the applications forms contained in the appendices have been replaced by online application forms.
Sep 2021	Online Skills Training Resources: Research Methods (change from 3 units to 2); Introduction to Statistics (title updated); Presentation Skills (additional final sentence)
	MSc Pharmaceutical Technology and Quality Assurance: updated names and contact details.
	Rationale and General Description: update to unit tiles of PHAR61790, PHAR61800 and PHAR61930, and text relating to PHAR61810.
	Programme Learning Outcomes: minor textual changes.
	Credit Requirements: minor textual changes.
	Dissertations: minor textual changes and updated Consortium Lead.
	Criteria of Levels of Achievement: minor textual changes.
	Progression: correction of pass mark to 50%.
	Reassessment: correction of pass mark to 50%.
	Available Degree Classifications: minor textual changes.
	Late Submission Penalty (including the Dissertation): updated heading, addition of hyperlink to the University Policy on Submission of Work for Summative Assessment on Taught Programmes, minor updates to the text.
	Assignment Word Count (including the Dissertation): updated heading, reference to School procedures on word count penalties added.
	Submitting Work: expanded information on file formats for electronic submissions, reordering of points.
	Feedback for assessments: minor textual changes.
	Dissertations: Sentence added following hyperlink to Guidance for the presentation of Taught Masters dissertations.
	Attendance: Text added to specify that attending work will not normally be accepted as a reason for absence from the course.
	Requests for interruption: minor textual changes.
	Academic Appeals: updated advice on initial informal discussions, updated link to the Academic Regulations information (including Regulation XIX, Academic Appeals Procedure).
	Student Complaints: updated reference to the Student Complaints Procedure).
	Conduct and Discipline of Students: paragraph added relating to the Policy on Submission of Work for Summative Assessment on Taught Programmes, additional links to resources on Referencing and Avoiding Plagiarism, Good Study Skills, and avoiding academic malpractice.
	Sharing Information: updated link to the University’s Privacy Notice.
	Fitness to Practise: updated link to University information on Fitness to Practise
	Role of the External Examiner: updated heading, additional subheading, and removal of name pending the appointment of a new External Examiner.
	Unit specification, PHAR61780: updated Teaching and Learning Methods and Assessment details.
	Unit specification, PHAR61790: updated Unit Lead details, Teaching and Learning Methods and Assessment details.
	Unit specification, PHAR61800: updated title (from 2 to 2B), unit lead details, Teaching and Learning Methods and Assessment details.
	Unit specification, PHAR61900: updated Unit Lead, Teaching and Learning Methods and Assessment details.
	Unit specification, PHAR61910: updated Teaching and Learning Methods and Assessment details.
	Unit specification, PHAR61920: updated Unit Lead details, Teaching and Learning Methods and Assessment details.
	Unit specification, PHAR61930: updated title, Unit Lead and Assessment details.
	Unit specification, PHAR72090: updated Assessment details.
	Unit specification, PHAR61940: updated Assessment details.
	Divisional Administration Contacts: updated names and contact details.
	Student Centre: minor textual changes.
	Working with your own computer: minor revision of text.
	Blackboard, Training in the use of software: updated link to video and addition of explanatory sentence.
	Student Support: extra reference added to the Counselling Service.
	Academic Support Policies: updated link to Guidance for the Presentation of Taught Masters Dissertations and accompanying comment, updated link to Policy on religious observance for students (for UG/PGT and PGR students), updated link to guidance for healthcare students on fasting and caring.
	Throughout: Postgraduate Consortium Committee updated to Postgraduate Teaching and Learning Committee.

Introduction to the School of Health Sciences

Welcome from the Director of Post Graduate Taught Education

$\\nask.man.ac.uk\home$\Downloads\thumbnail_Andrew%20Mawdsley.jpg$ I am delighted to welcome you to the School of Health Sciences and the Faculty of Biology, Medicine and Health. We are extremely pleased you have chosen The University of Manchester to commence or continue your postgraduate study journey; whether you are progressing straight from your undergraduate studies, seeking to develop your knowledge/skills in your chosen career or are, bravely, taking a completely different direction in life.

In the pursuit of knowledge, wisdom and humanity, we will place you at the centre of a transformational learning process to support you to achieve your individual goals and aspirations. Our challenge to you is to embrace all of the opportunities available to you; be bold, think differently and realise your potential. We want your postgraduate journey with us to be intellectually stretching, rewarding and fun.

We are aware that most of you will need to juggle a number of competing priorities during your postgraduate taught studies. Some of you will already be in full time employment, while others will need to secure part time employment to fund your studies. We know that many of you will have family and caring responsibilities that will have to be prioritised before your own learning. We hope the information detailed in this programme handbook will help you in managing these competing commitments. Whether you are joining us on campus, or studying at a distance, you are an integral part of our School and University, and we are here to support you.

We are extremely proud of our postgraduate student community and alumni who are making a difference, both locally and globally. We look forward to working with you, confident that you too will play a role in transforming the lives of people who use health and social care services, whether during your studies or upon graduation.

I wish you every success in your postgraduate studies here at The University of Manchester.

$\\nask.man.ac.uk\home$\Downloads\sig2.jpg$

Mr Andrew Mawdsley
Director of Post Graduate Taught Education
School of Health Sciences

Introductory Courses

All students are automatically enrolled onto an introductory unit (SHSS60001 Introductory Courses) that provides information on health and safety, academic malpractice and academic literacy. Completion instructions for each of these sections are clearly defined within the course.

Completion of the academic malpractice and health and safety sections is mandatory for all students. All assessments must be completed as soon as possible after the programme begins, with the academic malpractice assessment completed before the first piece of coursework is submitted.

All students are also strongly advised to complete the academic literacy section. Completion of these assessments is monitored by the School.

Online Skills Training Resources

The Faculty has developed a skills training resource to support you through your postgraduate taught programme. This online material should supplement the assessed learning material and activities undertaken in your taught programme.

Accessing the online skills resource

You can access Blackboard through the My Manchester portal (http://my.manchester.ac.uk). The skills training resource is available in an academic community space available to all registered PGT students in the Faculty through Blackboard.

If you cannot see these units in your Blackboard please contact your Programme Administrator.

Content

Full details of all these resources can be found in the introduction to each unit. These resources have been designed to give you formative feedback on your progress through them. If you experience any problems and would like to talk to someone please contact your Programme Director. If you have questions about referencing and how it applies to your own work, please contact your Programme Director or dissertation supervisor/module lead.

Research Methods*	This course is spilt into 2 units that cover introductions to study design, statistics and dissertation skills. It has a number of online quizzes where you can test your knowledge.
Introduction to Statistics*	The course provides a valuable foundation for understanding and interpreting biostatistics. It aims to provide you with the fundamentals of quantitative analysis.
Presentation Skills	This short interactive unit is designed to help you to enhance your presentation skills. Regardless of whether you are presenting in public, preparing for conferences, an oral examination or more informal settings this unit will give you the tops tips to improve your delivery. The course also includes a unit on influencing effectively, alongside the presentation and poster information.
Qualitative Research Methods*	This unit has been designed to give you an introduction to Qualitative Research.
Intellectual Property Awareness Resource	This Intellectual Property (IP) awareness resource has been created in order to improve your understanding of IP. Topics include: Types of intellectual property • Copyright and IP clearance • University policy on IP • IP commercialisation • IP in research or consultancy • IP issues to be aware when dealing with academic materials

* NOTE: the material in this online resource is for reference and formative learning purposes only. In some of your taught programme you may be required to undertake assessed course units for Research Methods, Qualitative Research or Statistics. If your programme involves taught units then you should refer to the Blackboard material relating to that course unit. Please contact your Programme Administrator if you are unsure which material relates to your assessed work. You will still be able to refer to the online skills resource in later years.

Welcome to the Programme

MSc Pharmaceutical Technology and Quality Assurance

Welcome to the Pharmaceutical Technology and Quality Assurance postgraduate programme.

This student handbook provides details of the University of Manchester Programme leading to the MSc in Pharmaceutical Technology and Quality Assurance and the Diploma/Certificate (exit awards). It includes information about the aims and learning outcomes, structure, content, admissions, assessment and programme management. Please read it thoroughly. It should also be read in conjunction with related University documentation.

In Section A, there is a summary of how the course is structured while, in Section B, each of the course units are described. Section C contains practical information about the School, and Section D the various University Regulations.

Each of you will bring your personal experience and knowledge to the programme. Sharing that knowledge and experience with your tutors and other students in person and through the online discussion boards will significantly enhance the learning experience.

We have made every effort to provide you with the most up-to-date and accurate information. However, some minor details may change during the course of your studies. All changes and additions will be brought to your attention. If there is something not answered within the handbook please do not hesitate to contact us.

We hope that your time studying with Manchester will be enjoyable and successful.

General information about the Division of Pharmacy and Optometry, staff listings and research interests are contained in this handbook, but more information can be obtained from the following web sites:

The Pharmacy home page:
https://www.bmh.manchester.ac.uk/pharmacy/
The Faculty of Biology, Medicine and Health home page:
https://www.bmh.manchester.ac.uk/
The University of Manchester home page:
http://www.manchester.ac.uk/

Ruth Barnes
Programme Director
Division of Pharmacy and Optometry
Stopford Building
Tel: 0161 306 2343
Email: ruth.barnes@manchester.ac.uk
ptqa.stp_pds@manchester.ac.uk

Sue Renn
Deputy Programme Director
Division of Pharmacy and Optometry
Stopford Building
Tel: 0161 306 2343
Email: sue.renn@manchester.ac.uk
ptqa.stp_pds@manchester.ac.uk

Emma Davies
Lecturer in Pharmaceutical Sciences
Division of Pharmacy and Optometry
Stopford Building
Tel: 0161 306 2343
Email: emma.davies-9@manchester.ac.uk
ptqa.stp_pds@manchester.ac.uk

Emma Sturgess
Postgraduate Programmes Manager
Division of Pharmacy and Optometry
Stopford Building
Email: emma.chaplin@manchester.ac.uk

Postgraduate Programmes Support Team
Division of Pharmacy and Optometry
Stopford Building
Tel: 0161 306 0597 / 0161 275 2371
Email: ptqa.stp@manchester.ac.uk

Section A: Programme Structure

Rationale and General Description

The aim of the Pharmaceutical Technology and Quality Assurance (PTQA) programme is to develop NHS, and industry staff, in the technical pharmacy specialties related to manufacture of medicines including manufacturing, aseptic compounding, radiopharmacy, clinical trials, quality assurance and quality control. The programme will equip students with the necessary transferable, intellectual and professional skills to permit them to develop their academic and professional potential throughout their career by fostering lifelong learning in the pursuit of excellence in scholarship and practice.

The programme is part-time and delivered over a 3 year period. The taught elements are delivered in discrete blocks and are integrated around work-based practice.

Year 1

During the first year of the course, students attend a number of course units covering a wide range of topics on:

Compulsory unit:

PHAR61780 Foundations of Pharmaceutical Technology and Quality Assurance

Optional units (choose 1):

PHAR61790 Introduction to Clinical Pharmaceutical Science 2A
Radiopharmacy
Aseptics
Formulation Sciences
PHAR61800 Introduction to Clinical Pharmaceutical Science 2B
Production
Aseptics
Formulation Sciences

Year 2

During the second year of the course, students attend course units covering:

Compulsory units:

PHAR61900 Quality Control
PHAR61910 Aseptics Advanced

Optional units (choose 2):

PHAR61930 Pharmaceutical Medical Gas Testing
PHAR61920 Pharmaceutical risk management and the role of the QP
PHAR72090 Clinical Trials for the NHS
PHAR61940 Radiopharmacy Advanced
Pharmaceutical Industry Advanced Training Programme (PIAT) units which meet the learning objectives of PTQA

Year 3

Students who opt for the third year of the course will undertake a research project (PHAR61810).

The taught element of the course comprises seminars, workshops and several forms of independent learning. Throughout the third year, students will also be working on a dissertation, which involves a substantial piece of empirical work. Dissertation topics are chosen and developed by students in consultation with their supervisor and the programme team.

Programme Aims

Students will become members of a School that leads research and development in areas of pharmaceutical technology and quality assurance. The ethos fosters excellence in pure and applied research and in developing treatment approaches. The educational aims of the programme are to provide students with an understanding of core principles and features of pharmaceutical technology and quality assurance or professional training. The course will produce students who:

Critically apply knowledge of pharmaceutical technology and quality assurance to a range of specialist medicines management areas in the field of pharmaceutical technology and quality assurance.
Critically analyse evidence to make judgements regarding complex quality assurance issues in pharmaceutical practice.
Lead on enhancing the achievement of standards and upholding necessary standards and legal requirements in specific areas of practice.
Apply in-depth knowledge and experience of techniques for evaluating and managing the risks to patients from pharmaceutical technology and quality assurance.
Take a proactive and self-reflective role in working.
Critically and creatively evaluate current issues in practice and conduct research which advances pharmaceutical technology and quality assurance.

Programme Learning Outcomes

Students, on successful completion of the MSc programme, will be able to:

Apply knowledge of pharmaceutical technology and quality assurance to specific areas of practice related to their career pathway.
Display a critical understanding of the regulatory processes and practices involved in conducting research in a health service or academic setting.
Understand the role of the technical services professional in ensuring the safety of the patient, particularly related to manufacture and quality control with reference to key patient care pathways.
Discuss the principles of Quality Assurance, EU Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems and be able to critically evaluate the application of regulatory controls.
Describe and critically evaluate the classification of controlled areas, the monitoring of such areas and the gowning requirements. Students should be familiar with the routine operation and cleaning of facilities and clean air devices.
Explain the principles of aseptic manipulation and discuss the key standards, practices and Quality Assurance arrangements relating to aseptic preparation and dispensing of medicines and their application to patient safety and patient centred care.
Describe the principles of pharmaceutical formulation (properties of excipients and ingredients, criticality of final packaging, principles of sterilisation) and manufacturing. Students should be able to explain the factors affecting formulation, stability and preservation.
Discuss the role of pharmacy technical services staff in radiopharmacy in the diagnosis and treatment of disease using radiopharmaceuticals and be able to recognise the different types of radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use.
Discuss the importance of radiation hygiene and safe working in radiopharmaceutical preparation.
Systematically and critically employ the knowledge and understanding obtained during the taught component of the programme to address an original research question through the design and undertaking of a comprehensive research project and production of a dissertation.
Critically reflect on and challenge their own practice, the practice of others and the organisation and delivery of pharmacy technical services in order to ensure use of appropriate values and best practice in delivering patient care and management.
Appraise and interpret information from different sources in order to develop a coherent critical analysis of issues relating to the practice and delivery of pharmacy technical services.
Perform detailed investigations in order to establish the root cause of exceptions using a variety of tools available. To perform detailed risk assessments and to allocate appropriate corrective and preventive actions (CAPA).
Critically evaluate the performance of new analytical technologies in the context of the specific requirements of the health service.
Critically analyse and objectively evaluate data from the key performance indicators of the Pharmaceutical Quality System.
Critically appraise the impact of the pharmaceutical production process on the quality of the clinical outcomes.
Synthesise, analyse and systematically combine information obtained from different sources to develop a defined original research question and then to address it through the development of a coherent research project.
Interpret and interrogate scientific data statistically leading to the generation of valid and defensible scientific conclusions.
Apply the principles of EU Good Manufacturing Practice (GMP) to develop a safe new product.
Use and critically review a Pharmaceutical Quality System; use a change control system, evaluate internal and external auditing.
Perform all manufacturing activities in accordance with requirements for Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems.
Lead on enhancing the achievement of standards and upholding necessary standards and legal requirements in pharmacy technical services.
Work within the principles and practice of instruments, equipment and methodology used in pharmacy technical services.
Make judgement on the effectiveness of processes and procedures. Contribute to the strategies for practice development and change at both a team and organisational level to enhance access to and effectiveness of pharmacy technical services.
Design a scientifically valid experimental strategy to address a specific research question relevant to modern pharmacy technical services.
Produce a cogent dissertation that contains a critical analysis and evaluation of data generated during a research project, and a concise and scientifically valid interpretation of the experimental findings.

A copy of the programme specification can be found on the PTQA Virtual Common Room on Blackboard.

Details of the aims and learning outcomes associated with specific course units are found under the appropriate headings in Section B.

Credit Requirements

To be awarded a degree, you have to accumulate the requisite credits by passing the assessments for course units and thus gaining the credits associated with them. Students must accrue 180 postgraduate credits to qualify for the degree of MSc. The Awards of Postgraduate Diploma (requiring 120 credits), and Postgraduate Certificate (requiring 60 credits) are also available. Students may be permitted to receive an award of credits on the basis of demonstrated learning that has occurred at some point in the past (Accreditation of Prior Experiential Learning – APEL), either through awards from an educational institution or training provider, or through uncertified learning gained from experience. Further details on Credit Requirements and APEL can be found in the Postgraduate Taught Regulations Document.

Supervisory Arrangements

Each student will be allocated an academic advisor at the start of the programme. The University defines the role of academic advisor as follows:

To assist students with the process of induction and orientation into academic life and the University community and respond promptly to any communication from him/her;
To work with students to build personal academic relationships;
To retain an interest in their students’ personal and general academic and professional development throughout their academic careers while at the University, providing information and guidance on academic choice;
To monitor both academic performance and student engagement in a proactive manner and advise on constructive strategies to enable improvement, for example through the use of a personal portfolio or personal development plan;
To offer general academic advice to their allocated students on their general progress and development towards the fulfilment of the Purposes of a Manchester Education, and to signpost relevant careers and skills development provision to enhance employability;
To listen and offer students help and advice about pastoral/non-academic matters and to signpost students to other student services for further assistance if necessary;
To ensure that a note is kept of discussions at each meeting (with the student) and any follow-up actions agreed with the student;
To provide references.

Dissertations

The dissertation (PHAR61810) involves a student working closely with their supervisor to develop and implement an empirical research project. All students taking the MSc are required to submit a research proposal for the research project, which must provide details of a work-based supervisor. The research proposal will be reviewed by a team of academic staff who will allocate an appropriate academic supervisor.

The University defines the role of supervisor as follows:

Giving guidance about the nature of research and the standard expected, the planning of the research programme, literature and sources, attendance at taught classes where appropriate and about requisite techniques (including arranging for instruction where necessary);
Maintaining contact through regular meetings (the frequency of meetings being appropriate to the research being undertaken and agreed in advance);
Being accessible to the student at other appropriate times for advice and responding to difficulties raised by the student;
Giving detailed advice on the necessary completion dates of successive stages of the work so that the thesis may be submitted within the agreed timescale;
Requesting written work or reports as appropriate and returning written material with constructive criticism and in reasonable time;
Ensuring that for degrees where an oral examination is required the student is adequately prepared by arranging for the student to present his or her work to staff and graduate seminars.
Ensuring that the student is made aware when progress is not satisfactory and facilitating improvement with advice and guidance;
Establishing at an early stage the Supervisor’s responsibilities in relation to the student’s written work, including the nature of the guidance and comments to be offered as the work proceeds and on the draft of the thesis before it is submitted. It must be made clear to the student that research for a higher degree is undertaken within the general principle that a thesis must be the student’s own work;
Making students aware of other researchers and research work in the department;
Providing pastoral support and advising students, where appropriate, of University support services;
Bringing to the attention of the students the health and safety regulations and academic rules, regulations and codes of practice of the University.

The relationship between the Student and his/her Supervisor is of central importance. Both the Student and the Supervisor have a responsibility to ensure that the dissertation is completed within the prescribed period of the programme. Supervisors and students should establish at their initial meeting clear and explicit expectations of each other in order to minimise the risks and problems of misunderstanding, personality clashes, inadequate supervision and unsatisfactory work. Timetables for Progress Monitoring meetings must be closely observed.

If you have any queries or concerns at any time during your period of study, there is a range of people you can approach:

Your Student Representatives
The Programme Administrator
Your Supervisor
Your Adviser
The Programme Director
The Consortium Lead (Dr Alain Pluen)
The Head of Division (Prof. Jayne Lawrence)

Course Assessments

Full details of modes of assessment for each Course Unit are provided in Section B.

The programmes contain a range of both formative and summative assessment tasks which have been designed to establish students’ knowledge and understanding of the stated learning outcomes for the course unit.

Formative assessments

These are developmental assessments which assess your learning as you work through the unit and whenever possible form part of the preparatory work for, and link to, the summative assessments.
Formative assessments do not contribute towards the final mark but are an important part of your assessment, in that feedback from these assessments will enable you to develop and improve before moving on to the summative assessment.
Formative assessments are marked as a pass or fail, feedback will be offered to guide your learning.
You must attempt all formative assessments within a course unit and if you do not pass you should discuss your learning needs with the course unit lead.

Summative assessments

Each unit includes at least one summative assessment. These have been designed to assess your learning and the practice-based application of it.
Each assessment task is allocated a percentage weighting towards the final mark.
The minimum weighting of any individual summative assessment will be 10%.

Criteria of Levels of Achievement

To obtain a pass for the Postgraduate Certificate you are required to successfully pass 60 credits, for the Postgraduate Diploma you are required to successfully pass 120 credits, and for the Masters you are required to successfully pass 180 credits. You must achieve a mark of at least 50% in all summative assessment components within a course unit to achieve a pass.

You will be eligible for the award of a distinction, at Masters level only, provided you achieve an average mark of 70% or more, based on the weighted programme as a whole. If credit has been awarded as a result of referral, you will not be eligible for the award of distinction.

You will be eligible for the award of a merit, at Masters level only, provided you achieve an average mark of 60% or more, based on the weighted programme as a whole. If credit has been awarded as a result of referral, you may still be eligible for the award of merit.

Postgraduate Taught Degree Regulations for Students

Postgraduate Taught degrees at the University of Manchester are based on the National Framework for Higher Education Qualifications (FHEQ). This framework requires students to achieve credit at Masters level in order to get an award. For a standard postgraduate taught Masters programme this will normally mean passing 180 credits. A standard Postgraduate Diploma will normally have 120 credits and a Postgraduate Certificate 60 credits. The way in which you study these credits will be defined later in the programme handbook and the programme specification.

The University sets standards relating to your performance on every unit but also on your progression through the programme. Your programme and course unit specifications will set out the requirements for passing the credit on individual units.

The full PGT Degree Regulations can be accessed at:

http://www.regulations.manchester.ac.uk/postgraduate-degree-regulations/.

The following guidance should be read in conjunction with the Introduction to the Postgraduate Degree Regulations for Students:

http://www.tlso.manchester.ac.uk/degree-regulations/

Exemptions to the PGT Degree Regulations:

Please be aware that the PTQA programme has some higher requirements to the University degree regulations and details of these are outlined below.

The course unit pass mark for all levels (ie Postgraduate Certificate, Diploma and Masters) is 50%.
The programme will operate a 50% pass rate across all assessments
The programme will not apply any compensation rules
An average mark of 50% must be achieved for each course unit with no individual component mark below 50%
In accordance with the University’s PGT Degree Regulations, the resit pass mark is 50% but this mark will be capped at 40% (unless the previous mark was within the compensation zone (40-49%) in which case the original mark will stand) and it is this mark that will be used to calculate the programme GPA.
As a requirement of the professional body, a resit pass mark will be recorded as 50R on the University transcript but the programme GPA will be calculated as described under the above point (ie as 40% or between 40% and 49% if the original mark was in the compensation zone).

Criteria for Awards

Award of Masters Degree

The award of Master degree is based upon credit accumulation using a pass mark of 50%.

Distinction

Exceptional achievements over the course of the Programme according to the taught masters marking scheme will be rewarded with the degree of Masters with Distinction.

To obtain a Distinction, students must have:

accrued 180 credits;
have passed all units with no referrals;
have achieved an overall weighted average of 70% or more across the programme;

Students who have been compensated or have been referred in any course units are not eligible for the award of Distinction. In addition, the dissertation must be submitted by the end of the period of programme, unless there are significant mitigating circumstances, approved in advance, for missing the end of programme deadline.

Merit

To obtain a Merit, students must have accrued 180 credits AND have achieved an overall weighted average of 60% or more across the programme, including any provision made for referred units.

Pass

To obtain a pass, students must have accrued 180 credits including any provision made for referred units.

Progression

To progress to the dissertation / research element of the Masters programme, students must have passed all taught units (120 credits).

Award of Postgraduate Diploma

To obtain a Postgraduate Diploma award, students must have accrued 120 credits (as specified by the programme), including any provision made for referred units.

Award of Postgraduate Certificate

To obtain a Postgraduate Certificate award students must have accrued 60 credits (as specified by the programme), including any provision made for referred units.

Unless otherwise specified in the exemptions, the awards of Postgraduate Diploma and Postgraduate Certificate degree are based upon credit accumulation using a pass mark of 50% for which there is no classification other than pass/fail.

Exit Awards

Exit awards are available for students who do not satisfy the criteria for the programme they are registered on or who need to exit the programme early due to unforeseen circumstances.

To be considered for a PG Diploma (120 credits; exit point) students must have accrued 120 credits across the programme.

To be considered for a PG Certificate (60 credits; exit point) students must have accrued 60 credits across the programme.

Reassessment

Reassessment as a result of a fail is known as a “Referral”. Reassessment as a result of approved and verified mitigating circumstances is known as “Deferral” and may be permitted where students are reassessed as a first attempt, for which no penalty applies.

Students may be referred in up to half of the total taught credits. The combined total number of credits referred on PTQA cannot exceed half the taught credits. Decisions with regard to which components should be reassessed are made by the Examination Board. When a student is referred they will normally be permitted to retake the assessment/exam on one further occasion.

At the recommendation of the Board of Examiners, students will normally be allowed one resubmission of a failed dissertation or project and this will normally be within four months of the date of the publication of the result.

The pass mark for a reassessment is the same as the first attempt (i.e. 50% for masters and 50% for Postgraduate Diploma/Certificate). When a reassessment is passed, the mark is capped at the lowest compensable fail mark (i.e. 40R), unless the previous mark was within the compensation zone, in which case the original mark will stand with a suffix ‘R’. This mark is used in the weighted average/total mark for the final award. The capped mark is applied to the whole unit and not the failed component.

Please refer to the ‘Programme Exemptions to PGT Degree Regulations’ section of the handbook, where specific exemptions applicable to the programme will be listed.

Available Degree Classifications

Overall programme mean average of 50.0% or more Certificate Pass
with 60 credits successfully completed

Overall programme mean average of 50.0% or more Diploma Pass
with 120 credits successfully completed

Overall programme mean average of between 50.0%-59.9% MSc Pass
with 180 credits successfully completed

Overall programme mean average of between 60.0%-69.9% MSc with Merit
with 180 credits successfully completed

NB If either the Taught Average or Dissertation mark falls within the buffer zone of 58.0-59.9 the student may be considered for the award of Merit. For further information please see the Postgraduate Taught Regulations.

Overall programme mean average of ≥ 70% MSc with Distinction
with 180 credits successfully completed
and no mark < 50% on any Course Unit at first attempt

NB If either the Taught Average or Dissertation mark falls within the buffer zone of 68.0-69.9 the student may be considered for the award of Distinction. For further information please see the Postgraduate Taught Regulations.

Students who register originally for a Diploma, but subsequently wish to transfer to the MSc course, will be allowed to do so if they attain, in assessments of the taught Course Units, the level of achievement specified above for the award of the MSc.

Students must be awarded 120 credits before being permitted to progress to the Dissertation stage of the programme.

Deadlines for Assessed Work

All assessed work must be handed in at the prescribed time. Submission deadlines are published on Blackboard. WE RECOMMEND THAT YOU TRANSFER THESE DATES TO YOUR DIARIES AS SOON AS THEY ARE PUBLISHED.

If there is a problem which prevents you submitting the assessment on time you must bring it to the attention of the Programme Support Team (ptqa.stp@manchester.ac.uk) promptly, before the assessment submission date. Depending on the length of time you require to complete the assessment you will then need to apply for an extension of up to a maximum of two weeks for circumstances such as acute illness. If you need to request an extension you must complete the online Extension Application Form and send your supporting evidence to dpo.pgt@manchester.ac.uk. Make sure you provide your name, University ID number and programme in the message. Please provide as much detail as possible when completing the form and please be assured that all information will be treated confidentially.

Extensions will be granted at the discretion of the Programme Director (course unit leads do not accept extension requests). For all assignments other than practice journals, you are permitted a maximum extension of two weeks. Two week extensions are only granted for acute illness around assignment submission time and any unforeseen life events that affect your ability to work in the short-term. For practice journals ONLY, extensions of over two weeks will be granted at the discretion of the Programme Director.

The process for requesting an extension is:

Complete the online Extension Application Form
Send supporting evidence to dpo.pgt@manchester.ac.uk (with your name, ID number and programme)
Extension request is sent to unit lead for review
Final decision is communicated by the Programme Support Team.
Submit your work by the agreed extension date via the original submission method

Late Submission Penalty (including the Dissertation)

Work submitted after the deadline without prior approval will be subject to a late penalty in accordance with the University Policy on Submission of Work for Summative Assessment on Taught Programmes. The penalty applied is 10% of available marks deducted per day/24 hours (from the time of the original or extended deadline), until the assignment is submitted or no marks remain.

Penalties for late submission relate to 24 hours/calendar days, so include weekends and weekdays, as well as bank holidays and University closure days.

The mark awarded for the piece of work will be reduced by:

• 10% of the available marks deducted if up to 24 hours (1 day) late
• 20% of the available marks deducted if up to 48 hours (2 days) late
• 30% of the available marks deducted if up to 72 hours (3 days) late
• 40% of the available marks deducted if up to 96 hours (4 days) late
• 50% of the available marks deducted if up to 120 hours (5 days) late
• 60% of the available marks deducted if up to 144 hours (6 days) late
• 70% of the available marks deducted if up to 168 hours (7 days) late
• 80% of the available marks deducted if up to 192 hours (8 days) late
• 90% of the available marks deducted if up to 216 hours (9 days) late
• 100% of the available marks deducted if up to 240 hours (10 days) late

If the assessment is submitted within 10 calendar days of the deadline, the assessment should be marked and feedback to the student provided. If this mark before the penalty is applied reaches the appropriate pass mark but the applied penalty results in a fail of the assessment, the student should not be required to resit the assessment as the original mark can be taken in lieu of a resit/referral and normal resit/referral procedures will apply. Further information and examples can be found in the Policy and associated Guidance documents below.

For work submitted more than 10 days late, it is regarded as a non-submission and need not be marked. In this case a mark of zero will be awarded and normal resit procedures will apply.

The sliding scale should only be applied to first-sit submissions. For all referred (resit) assessment, any late submission will automatically receive a mark of zero.

For further information:

Guidance on Late Submission

Policy on the Submission of Work for Summative Assessment on Taught Programmes

Mitigating Circumstances

If you are experiencing longer term problems you should follow the mitigating circumstances route. If during the course of the year you experience any mitigating circumstances which you think may have an adverse effect on your academic performance (for example prolonged illness or bereavements) you must complete the online Mitigating Circumstances Form. You must also forward your supporting evidence to dpo.pgt@manchester.ac.uk before the assessment submission deadline. Make sure you include your name, University ID number and programme in the message.

The process for submitting mitigating circumstances is:

Complete the online mitigating circumstances form
Send your supporting evidence to dpo.pgt@manchester.ac.uk (with your name, ID number and programme)
Programme support team confirm receipt and the date of the next mitigating circumstances panel meeting
Mitigating circumstances panel meet and agree on outcomes of application
Programme support team communicates the panel’s decision by email

The Policy on Mitigating Circumstances can be accessed here:
http://www.campus.manchester.ac.uk/tlso/map/teachinglearningassessment/assessment/sectionc-reachingdecisionsfromassessment/policyonmitigatingcircumstances/

Guidance for students on mitigating circumstances can be found here:
http://www.tlso.manchester.ac.uk/map/teachinglearningassessment/assessment/sectionc-reachingdecisionsfromassessment/mitigatingcircumstancesguidanceforstudents/

A basic guide to mitigating circumstances can be accessed here:
http://www.regulations.manchester.ac.uk/basic-guide-mitigating-circumstances/

Assignment Word Count (including the Dissertation)

In accordance with the University Policy on Marking, Schools must have procedures in place to apply a penalty if the word count exceeds the word limit by more than 10%.

Each written assignment has a word limit, which you must state at the top of your first page. It is acceptable, without penalty, for you to submit an assignment within a range that is plus 10% of this limit. If you present an assignment with a word count exceeding the specified limit+10%, the assignment will be marked but 1% will be deducted from this mark for every 100 words over the limit given.

For an original word limit that is 1000 words and an assignment that is marked out of 100. If a submission is made that is 1101 words then it exceeds the 10% leeway, and is more than 100 words over the original limit and should receive a 1 mark deduction.

In accordance with accepted academic practice, when submitting any written assignment for summative assessment, the notion of a word count includes the following without exception:

All titles or headings that form part of the actual text. This does not include the cover page or reference list.
All words that form the actual essay.
All words forming the titles for figures, tables and boxes, are included but this does not include boxes or tables or figures themselves.
All in-text (that is, bracketed) references.
All directly quoted material.

Certain assessments may require different penalties for word limits to be applied. For example, if part of the requirement for the assessment is conciseness of presentation of facts and arguments. In such cases it may be that no 10% leeway is allowed and penalties applied may be stricter than described above. In such cases the rules for word count limits and the penalties to be applied will be clearly stated in the assessment brief and in the submission details for that assessment.

Where these mark reductions result in a fail, the unit will be treated as a failed unit in accordance with the University’s Degree Regulations.

Submitting work

The filename MUST contain your ID number then your assignment title,

e.g. 7123456 Assignment 1.

DO NOT save the work as ‘Essay’ or as the title of the work.

All assignments must include a cover page with the unit title, assignment question and your student number. Do not include your name as assignments are marked anonymously. Please see below for an example:

The University of Manchester

PHAR71010 – Basic Principles

(Assignment title)

(Submission date)

(Final word count)

(Student ID)

DO NOT PUT YOUR NAME ON THIS DOCUMENT.

When creating your document please ensure your ID number is on each page (in the header or footer) and your name does not appear on the document.

All assignments must be submitted electronically via SafeAssign. The published deadlines for assessments all relate to the electronic submission which is done via Blackboard and the SafeAssign system. You must submit by the deadline published.

Submitting an electronic copy of the work

Log onto Blackboard via the MyManchester : https://login.manchester.ac.uk/cas/login
Click on the relevant course unit
Click on ‘Course Tools’ in the column on the left of the page
A dropdown menu will appear, go to ‘SafeAssign’ then ‘SafeAssign items’
All assessments for that unit will appear – click on the relevant once and follow the submission process
An on-screen receipt for your assignment will be shown once submitted
For a how-to video on submitting via Blackboard, please follow this link – https://www.youtube.com/watch?annotation_id=annotation_913066741&feature=iv&src_vid=7ZuZW9-KAjY&v=oI3X0XW-xkI
If you have any problems accessing the student portal contact http://www.itservices.manchester.ac.uk/contacts

Please remember you can only upload one document so you cannot save your references as a separate document.

The electronic copy is your official record of submission.

Blackboard Assignment – SafeAssign

The University uses electronic systems for the purposes of detecting plagiarism and other forms of academic malpractice and for marking. Such systems include SafeAssign, the plagiarism detection service used by the University.

As part of the formative and/or summative assessment process, you may be asked to submit electronic versions of your work to SafeAssign and/or other electronic systems used by the University (this requirement may be in addition to a requirement to submit a paper copy of your work). If you are asked to do this, you must do so within the required timescales.

The School also reserves the right to submit work handed in by you for formative or summative assessment to SafeAssign and/or other electronic systems used by the University.

Please note that when work is submitted to the relevant electronic systems, it may be copied and then stored in a database to allow appropriate checks to be made.

Feedback for assessments

The purpose of feedback is to provide constructive criticism and encouragement so that you can improve your standards as time goes on. Thus in addition to marks we will give you written feedback on most of your assessed coursework and give it back to you.

All summative assessments will be double marked. Marks awarded for your summative assessments (i.e. everything which contributes to your final mark) are subject to moderation by the examination board and the external examiner. Consequently all marks given to students before the final examiners’ meeting has taken place must be regarded as provisional. Shortly after the examinations meetings we will publish final results to the Student System.

When you have graduated you may obtain a detailed official written account of all your examination results (called a transcript) from the Student Services Centre on payment of a small fee. This carries the University stamp and is recognised for such purposes as admission to a further course of study at another institution (in the UK or abroad), membership of professional bodies, exemption from sections of professional examinations and so on. If you need a transcript, contact the SSC on 0161 275 5000.

Return of Marked Work

Understandably students are keen to know their results and to receive back written work with comments. However, there must inevitably be a trade-off between the diligence of the marking process and the speed at which it takes place. Marks from assessed work must also be entered into our records, and this process is slowed by the need for painstaking checking to ensure accuracy. Students will be notified by email once the work has been marked and grades are available. We will endeavour to mark work and give feedback to students 15 working days after the hand-in date.

However, occasionally there may be delays as a result of staff illness or other unforeseeable factors.

The Policy on Feedback to Undergraduate and Postgraduate Taught Students can be accessed at the following link:

http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=6518

How to find your marks

Once work has been marked you will receive an email from the programme administrator to tell you that the marks have been released. Work submitted via Blackboard will usually show a mark along with feedback on the Blackboard system, through GradeMark.

You can also access marks by logging into your MyManchester account at https://www.portal.manchester.ac.uk/uPortal/render.userLayoutRootNode.uP and going to My Services/Self Service and Student Centre. You can choose ‘Assignments’ from the drop down box and choose the relevant module. Your final mark for the module doesn’t appear until the module is fully completed and marks have been through an exam board.

Examinations

Examinations run in the standard University exam period. The University publishes the dates of each examination period two years in advance, please refer to:

https://www.manchester.ac.uk/discover/key-dates/

Please be aware that you may be tested on any topic from within a module. Do not presume that because a piece of coursework has covered one area of a module that it will not also appear in the exam. Past papers for some modules (where appropriate) will be published on Blackboard. Do not assume that exams will take the same format as previous years. Academic staff should not indicate what will/will not feature in an exam as this may not be accurate. Staff may have submitted questions that may not, necessarily, appear on the final exam paper. You should presume that anything can appear on the exam paper unless informed officially by the Programme Administrator or Programme Directors.

Recording Lectures

Please do not assume you can record lectures with a voice recorder or other device. Please do not record lectures or other teaching sessions without obtaining the prior permission of the teacher. This does not apply to DASS registered students.

Dissertations

The dissertation involves a student working closely with their supervisor to develop and implement an empirical research project. Details of what is involved, and of how and when to submit the dissertation are provided on the Blackboard space for PHAR61810 Research Project.

The University has produced a document that gives guidance on the presentation of UG and PGT dissertations. A link to this document is provided below:

Guidance for the presentation of Taught Masters dissertations.

The guidance explains the required presentation of the dissertation, and failure to follow the instructions in the guidance may result in the dissertation being rejected by the examiners.

Monitoring Progress – Dissertations

In order to monitor progress, students will have regular, scheduled meetings with their dissertation supervisor. Progress forms should be completed at these meetings of which there should be a minimum of 6 per academic year for part-time students.

Attendance

Attendance at taught classes and supervision tutorials is compulsory and registers are taken. If your attendance is unsatisfactory then you will be reported to the Programme Committee and, ultimately, to the Pharmacy and Vision Sciences Postgraduate Teaching and Learning Committee. It is your responsibility to make sure you sign the register if one is circulated at a teaching session. Of course we realise that students will sometimes be absent for very good reasons due to personal or family circumstances, or illness; if this happens to you we will only know if you tell us, and we ask that you account for any period of absence which involves missing lectures or any other working session. In case of illness you should supply a doctor’s certificate or, if the illness is brief, a self-certification form. If you are absent for other reasons then you should write a letter to the Programme Director, submitted via the Programmes Administrator, explaining the circumstances. Medical certificates or letters should be given in person or sent to ptqa.stp@manchester.ac.uk. Please note that attending your workplace will not normally be accepted as a good reason for absence from the course. Whatever your reason for being away, tell your supervisor about it and make any necessary arrangements to catch up with work you have missed. If you have failed to hand in a piece of assessed work as a result of your absence, be sure you have complied with the rules outlined above for late submission.

The Programme Directors and the Programme Support Team monitor all cases of absence, and students who do not attend satisfactorily will be asked to give good reason for their lack of attendance or engagement. Students are reminded that in order to maintain adequate academic support from staff, they are required to attend all lectures.

The University Policy on Monitoring Attendance and Wellbeing of Students can be found at http://www.regulations.manchester.ac.uk/regulation-xx/

Requests for interruption

Students normally study for their award over a period of up to three years. However, the University recognises that it is sometimes necessary, in unfortunate circumstances, for people to interrupt their attendance. The regulations refer to this as “interruption”. An interruption allows students the chance to recover from such things as ill health. It is NOT a device to allow students to take time off because they fancy a break.

If approved, interruption would normally be granted for a period of 12 months. Thus a student would leave the University on a certain date and resume their studies on the anniversary of that date. Shorter periods of interruption are possible, but since they inevitably involve repeating some of the programme it is unusual for the University to allow them.

If you wish to interrupt you must complete the online Interruption Form and send supporting evidence to dpo.pgt@manchester.ac.uk, including your name, University ID number and programme.

The process for submitting a request for interruption is:

Complete the online interruption form
Send your supporting evidence to dpo.pgt@manchester.ac.uk (with your name, ID number and programme)
The Programme Support Team confirm receipt and the date of the next interruptions panel meeting
Interruptions panel meet and agree on outcome of application and any further action
The Programme Support Team confirms the panel’s decision by email

Withdrawal from studies

If for any reason you would like to withdraw from your studies, please contact the Programme Support Team (ptqa.stp@manchester.ac.uk) for further guidance. We will ask you to give notification of your withdrawal in writing, and you may be invited to speak to the Programme Director before your withdrawal is processed. Please note that you may be liable for part or whole of the tuition fees due and/or an administrative charge if you decide to withdraw once teaching has started.

Academic Appeals

Students have a right of appeal against a final decision of an Examination Board, or a progress committee, or a graduate committee or equivalent body which affects their academic status or progress in the University.

If you are considering appealing you should first discuss the matter informally with an appropriate member of staff in order to better understand the reason for the result or decision.

Should you wish to proceed to a formal appeal, this must be submitted within the timeframe outlined in the Academic Appeals Procedure to the Faculty Appeals and Complaints Team, Room 3.21, Simon Building, University of Manchester, M13 9PL (e-mail: FBMHappealsandcomplaints@manchester.ac.uk).

The full Academic Appeals Procedure (Regulation XIX) and associated documents, including the form on which formal appeals should be submitted, can be found at www.regulations.manchester.ac.uk/academic

Student complaints

The University’s Student Complaints Procedure (Regulation XVIII) and associated documents, including a complaints form, can be found at www.regulations.manchester.ac.uk/academic

The University has separate procedures to address complaints of bullying, harassment, discrimination and/or victimisation – see https://www.reportandsupport.manchester.ac.uk/

Students thinking of submitting a formal complaint should, in most instances, attempt informal resolution first (see the Student Complaints Procedure). Formal complaints should be submitted on the relevant form to Faculty Appeals and Complaints Team, Room 3.21, Simon Building, University of Manchester, M13 9PL (e-mail: FBMHappealsandcomplaints@manchester.ac.uk).

Conduct and Discipline of Students

General University information on the Conduct and Discipline of Students can be found at https://www.staffnet.manchester.ac.uk/tlso/academic-appeals-complaints-and-misconduct/conduct-and-discipline-of-students/.

Faculty policies for students on Communication and Dress Code, Social Networking and Drugs & Alcohol can be found at:

http://documents.manchester.ac.uk/display.aspx?DocID=29038 (Communication and Dress Code)
http://documents.manchester.ac.uk/display.aspx?DocID=29039 (Drugs & Alcohol)
http://documents.manchester.ac.uk/display.aspx?DocID=29040 (Social Networking)

Information on Academic Malpractice and how to avoid it can be found at http://www.regulations.manchester.ac.uk/guidance-to-students-on-plagiarism-and-other-forms-of-academic-malpractice/

In accordance with the Policy on Submission of Work for Summative Assessment on Taught Programmes, ‘All typed summative assessment, including dissertations, should be submitted online and subjected to plagiarism detection software, where appropriate’.

The University Library has produced online resources to help students in avoiding plagiarism and academic malpractice at:

https://www.library.manchester.ac.uk/using-the-library/students/training-and-skills-support/my-learning-essentials/online-resources/

An Introduction to Referencing and Avoiding Plagiarism is provided by the Student Guidance Service at:
An Introduction to Referencing and Avoiding Plagiarism (Student Guidance Service)

The Student Support website provides guidance on Good Study Skills at:
https://www.studentsupport.manchester.ac.uk/study-support/goodstudyskills/

The Student Support website also provides guidance on avoiding academic malpractice:
https://www.studentsupport.manchester.ac.uk/study-support/academic-support/accessing-online-teaching-and-learning/assessments-and-exams/avoiding-academic-malpractice/

Sharing Information

The University may share appropriate information relating to your health and/or conduct with external organisations such as your professional employer (for example, relevant NHS Trust Professional and Statutory Regulatory Bodies (PSRB), placement and training providers and/or regulator). This may occur where concerns in relation to your health and/or conduct arise and the University considers it necessary for them to be disclosed to one or more of the above organisations.

The University’s Privacy Notice for Registered Students (which is accessible via this link: www.regulations.manchester.ac.uk/data-collection-notice/) includes further information about how the University may use and process your personal data, including the legal basis and conditions which may be relevant to such processing (see section 6 of the Privacy Notice). The University will only disclose special category data (such as data relating to your health) to a third party organisation where one of the additional conditions are satisfied (see section 9 of the Privacy Notice), including where processing is necessary for reasons of substantial public interest.

Understanding Academic Malpractice

The University does not permit plagiarism or other forms of academic malpractice under any circumstances, and individuals found to have committed such an incident can expect a harsh penalty, which in some cases results in exclusion from the University. To ensure that you are fully informed about University expectations and understand your responsibilities with regard to academic malpractice please ensure you complete mandatory academic malpractice training in the Blackboard unit SHSS60001.

A copy of the University’s Academic Malpractice Procedure can be found at the following link:

http://documents.manchester.ac.uk/display.aspx?DocID=639

You can also access an online e-learning package on avoiding plagiarism via the University Library’s award-winning skills programme, My Learning Essentials.

If you have any doubts or further questions please contact the Programme Director.

Fitness to Practise

Information on Fitness to Practise related matters can be found at : https://www.staffnet.manchester.ac.uk/bmh/teaching/teaching-activity/fitness-to-practise/

Programme Management

The Programme Committee will be primarily responsible for monitoring the programme and will report directly to the Pharmacy and Vision Sciences Postgraduate Teaching and Learning Committee. This committee in turn reports to the School of Health Sciences PGT Committee. Special responsibility for the programme will be taken by the Programme Directors, the Consortium Lead for Postgraduate Taught Programmes and the Head of Division. The Programme Committee will, in liaison with the Pharmacy and Vision Sciences Teaching and Learning Committee, take responsibility for programme structure, development and delivery. The Programme Director will be responsible for admissions to the programme.

The Programme Director, in liaison with the Consortium Lead and the Postgraduate Programmes Manager, will be responsible for Quality Assurance for the programme.

Election of a Student Representative

Your representation plays a vital and important part in helping us to maintain and improve the quality of the programme we deliver. Early in Semester 1, students will be asked to select one individual to represent their interests to the MSc Programme Board. The student representative will be required to attend some compulsory training and attend one Programme committee per year. The reps will also organise group feedback sessions at the end of each semester for all students to voice opinions on the programme.

Student Evaluations

We will ask you to complete an evaluation form at the end of each teaching block. These questionnaires are reviewed by the unit leads and the Programme Director. The responses to these evaluations will be considered when reviewing the structure and content of the programme. Your feedback is extremely important, not only for programme quality assurance but also to the University in meeting the requirements of external quality assessment.

Role of the External Examiner

External Examiner are individuals from another institution or organisation who monitor the assessment processes of the University to ensure fairness and academic standards. They ensure that assessment and examination procedures have been fairly and properly implemented and that decisions have been made after appropriate deliberation. They also ensure that standards of awards and levels of student performance are at least comparable with those in equivalent higher education institutions.

External Examiner’s reports

External Examiner’s reports relating to this programme will be shared with student representatives at the programme board, where details of any actions carried out by the programme team/School in response to the External Examiner’s comments will be discussed. Students should contact their student representatives if they require any further information about External Examiner’s reports or the process for considering them.

The External Examiner for this programme is: TBA
Name of Institution: TBA
Position at current Institution: TBA

Please note that it is inappropriate for students to make direct contact with External Examiners under any circumstances, in particular with regards to a student’s individual performance in assessments. Other appropriate mechanisms are available for students, including the University’s appeals or complaints procedures and the UMSU Advice Centre. In cases where a student does contact an External Examiner directly, External Examiners have been requested not to respond to direct queries. Instead, External Examiners should report the matter to their School contact who will then contact the student to remind them of the other methods available for students. If students have any queries concerning this, they should contact their Programme Administrator.

Role and Responsibilities of Unit Leaders

To develop and update the unit specification in consultation with lecturers and programme directors, ensuring a coherent selection of teaching material and assessments to fit with the overall aim of the programme and its specifications
To liaise with programme administrators and the lecturers on their unit to ensure that the information on their unit in the programme handbook is accurate
To liaise with programme administrators and lecturers to organise examining, marking and student feedback
To develop and monitor the Blackboard E-Learning site for their unit, in liaison with lecturers for the sessions in their unit
To liaise with students concerning queries relating to teaching and assessments for the unit that are not specific to an individual teaching session
To attend programme meetings and the programme exam board in order to liaise with programme directors and student representatives
To consider and act upon student feedback, staff feedback, and external examiner feedback, in order to modify the structure, content and processes within their unit, in discussion with the programme team

Responsibilities of the Student

Pursuing the programme with a positive commitment, taking full advantage of the resources and facilities offered by the academic environment and, in particular, contact with the Supervisor, other staff and research students;
Discussing with the Supervisor the type of guidance and comment believed to be most helpful, and agreeing a schedule of meetings;
Ensuring that he/she is aware of the health and safety regulations and academic rules and regulations and codes of practice of the University;
Successfully completing any training programme arranged within the prescribed time period;
Taking the initiative in raising problems or difficulties, however elementary they may seem, bearing in mind that prompt discussion and resolution of problems can prevent difficulties and disagreements at a later stage;
Maintaining the progress of the work in accordance with the stages agreed with the Supervisor, including in particular the presentation of written material as required, in sufficient time to allow for comments and discussion before proceeding to the next stage. Where possible, students will be given details of the work programme for the academic year at the beginning of the year;
Agreeing with the Supervisor the amount of time to be devoted to the research and the timing and duration of holiday periods;
Checking the completeness and accuracy of the text of the thesis submitted; failure to check the thesis carefully may result in the thesis being failed or cause a delay in the award of a degree.

Section B: Syllabus, Course Units and Route through the Programme

Syllabus

Year One

Compulsory Components

PHAR 61780 Foundations of Pharmaceutical Technology and Quality Assurance (PTQA)

(30 credits)

Optional Components – choose 1 module from the following:

PHAR 61790 Introduction to Clinical Pharmaceutical Sciences 2A (30 credits)

PHAR 61800 Introduction to Clinical Pharmaceutical Sciences 2B (30 credits)

Year Two

Compulsory Components

PHAR61900 Quality Control (15 credits)

PHAR 61910 Aseptics Advanced (15 credits)

Optional Components – choose 2 modules from the following:

PHAR 61920 Pharmaceutical Risk Management and the Role of the QP (15 credits)

PHAR61930 Pharmaceutical Medical Gas Testing (15 credits)

PHAR61940 Radiopharmacy Advanced (15 credits)

PHAR72090 Clinical Trials for the NHS (15 credits)

Pharmaceutical Industry Advanced Training Programme units which meet the learning objectives of PTQA (15 credits)

Year Three

Compulsory Component

PHAR61810 Research Project (60 credits)

Course Units

Year One

PHAR61780 Foundations of Pharmaceutical Technology and Quality Assurance (PTQA)

Unit Leads: Mark Oldcorne (All Wales Specialist QA Pharmacist) and Ruth Barnes (UoM)

Credit Rating: 30 credits

Course Unit Aims

The unit provides the background knowledge required by the students undertaking the Pharmaceutical Technology and Quality Assurance (PTQA) programme. Students following different career paths will all require the core knowledge provided by this unit in order to progress through their own choices and to gain an appreciation of alternative routes through the programme.

The unit provides the students with an essential grounding in pharmaceutical quality assurance which underpins all GMP activities. Students will engage with lecturers and reading material to gain a full understanding of the regulatory framework governing pharmaceutical preparation and manufacture within the NHS.

It will also provide a fundamental understanding of Pharmaceutical Quality Systems (PQS) and the operational benefits and challenges of a robust system. The key documents of a PQS will be defined.

Course Unit Learning Outcomes

By the end of this course, students will be able to:

Discuss and critically evaluate the application of regulatory controls to pharmaceutical technology and Quality Assurance.
Discuss and critically evaluate the principles of Quality Assurance (QA) and EU Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems (PQS).
Implement the fundamentals of good document design throughout the whole PQS.
Design and construct manufacturing, Quality Assurance and Quality Control documentation.
Discuss in detail the health and safety aspects of Pharmaceutical Technology and Quality Assurance.
Describe and critically evaluate the process to be following when recalling a product from the market.
Describe and critically evaluate the three routes to obtaining a Manufacturing Authorisation including the associated timelines.
Describe the contents of an electronic Common Technical Document (eCTD) for a licensed product, with the Chemistry Manufacturing and Controls (CMC) section being described in detail.
Follow regulatory standards and guidance.
Evaluate scientific and clinical literature and present appropriately.
Critically appraise concepts and measures of quality and quality assurance and their links with the effective and efficient management of resources and improvement of service delivery.
Prepare technical documents; product specifications, investigation reports.
Prepare risk assessments using a variety of tools and techniques.
Interpret complex data and report on the findings.
Prepare for an internal or external audit.
Identify shortcoming in existing procedure and recommend change.
Assess the impact of change.
Read, interpret and apply standards and guidance to working practices.
Demonstrate professionalism and ethical awareness.
Communicate effectively with professional colleagues and service users.
Select and apply appropriate analysis or assessment techniques and tools.

Course Unit Content

The unit provides the fundamental background knowledge surrounding regulations and standards in order to operate successfully within pharmacy technical services.

Teaching and Learning Methods

Two online and one residential teaching blocksincluding lectures, workshops and discussion groups

E-Learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

Assessment

A 1,000 word formative written assignment.
A 2,000 word written assignment. This comprises 40% of the unit mark.
A 3,000 word group written assignment plus 1,000 word individual reflection. This comprises 30% of the unit mark.
A 20 minute group presentation plus 5 minutes of questions. This comprises 30% of the unit mark.

PHAR61790 Introduction to Clinical Pharmaceutical Sciences 2A

Unit leads:

ASEPTICS: Charlotte Ollerenshaw-Ward (Salford Royal NHS Foundation Trust) and Sue Renn (UoM)

PRODUCTION: Helen Callaby (Guy’s and St Thomas’ NHS Trust), Elizabeth Orr (Guy’s and St Thomas’ NHS Trust) and Ruth Barnes (UoM)

FORMULATION SCIENCES: Helen Callaby (Guy’s and St Thomas’ NHS Trust), Elizabeth Orr (Guy’s and St Thomas’ NHS Trust) and Ruth Barnes (UoM)

Credit Rating: 30 credits

Course Unit Aims

The unit aims to provide students with a background knowledge of formulation sciences, aseptic preparation and classical manufacture. The unit provides a good proportion of practical study enabling students to appreciate how the theory applies in practice.

The aseptic element provides students with an in-depth working knowledge of pharmaceutical microbiological aspects of aseptic manufacture and preparation. Students will also develop an ability to evaluate the use of cleanrooms and clean air devices in order to maintain patient safety.

The formulation sciences element will define the principles of pharmaceutical science and formulation. Students will understand the process of designing a new product and building the analytical specifications and stability studies in order to bring a new product to market.

Classical manufacture will prepare students to evaluate and develop services in production of pharmaceuticals. Content includes principles and management of pharmaceutical production, requirements of QA in application to theory and practice of manufacturing and sterilisation of products.

Course Unit Learning Outcomes

By the end of the course unit, students will be able to:

Production (10 credits)

Discuss the role of the technical services professional in ensuring the safety of the patient, particularly related to the manufacture of licensed and unlicensed products and Investigational Medicinal Products including cytotoxic drugs for the treatment of cancer.
Apply management principles to the detailed structure of the production process.
Describe the principles of Quality Assurance in relation to pharmaceutical production.
Show the relevance of pharmaceutical law and regulations.
Explain the process of product design.
Explain and critically evaluate the theory and practice of pharmaceutical manufacturing, assembly, preparation and dispensing.
Apply the principles of processing in regard to pharmaceutical production.
Explain the principles of sterilisation by irradiation, filtration, gas, moist and dry heat.

Aseptics (10 credits)

Understand the principles of design of facilities
Explain the principles of aseptic manipulation
Describe the principles of basic pharmaceutical microbiology
Analyse and interpret monitoring data and diagnose problems
Evaluate monitoring equipment and operational records
Explain the key chemical and physical reactions affecting the stability of medicinal products.
Resolve drug formulation and administration problems, particularly where they relate to the modification and optimisation.

Formulation Sciences (10 credits)

Describe the principles of pharmaceutical formulation and processing
Describe the properties of excipients and ingredients in pharmaceutical products.
Explain the factors affecting formulation, stability and preservation of pharmaceutical product
Perform mathematical calculations relevant to pharmaceutical formulation.
Describe the principles of sterilisation
Understand the criticality of final packaging

Course Unit Content

The aim of this unit is to provide students with the knowledge to underpin the divisional hospital-based professions. The unit contains three self-contained modules that are designed to provide students with an introduction to the theory and practice of each of the three main disciplines (Production, Aseptic and Formulation Sciences).

Teaching and Learning Methods

Teaching will be delivered as follows:
Production – 1 x 3 day online block
Formulation sciences – 1 x 3 day online block
Aseptics – 1 x 4-day online block,
Plus 1 x 5 day residential block.
These will include lectures, small group discussions, workshops, role-plays and experiential tasks. There will be e-learning material available.
Assessment
A 3,000 word integrated assignment covering Production, Aseptics and Formulation Science. . This comprises 100% of the unit mark.

Note: If you are submitting any of the Portfolios late, you must complete the online Extension Application Form and send your evidence to dpo.pgt@manchester.ac.uk (with your name, University ID number and programme).

PHAR61800 Introduction to Clinical Pharmaceutical Sciences 2B

Unit leads:

ASEPTICS: Charlotte Ollerenshaw-Ward (Salford Royal NHS Foundation Trust) and Sue Renn (UoM)

RADIOPHARMACY: Bev Ellis (Consultant Radiopharmacist, CMFT), Victoria Gibson (Chief Radiopharmaceutical Scientist, Guys and St. Thomas’s)

FORMULATION SCIENCES: Helen Callaby (Guy’s and St Thomas’ NHS Trust), Elizabeth Orr (Guy’s and St Thomas’ NHS Trust) and Ruth Barnes (UoM)

Credit Rating: 30 credits

Course Unit Aims

The unit aims to provide students with a background knowledge of radiopharmacy, aseptic preparation and product formulation. The unit provides a good proportion of practical study enabling students to appreciate how the theory applies in practice.

The radiopharmacy element allows students to appreciate the unique needs of the department in ensuring radiation protection.

Course Unit Learning Outcomes

By the end of the course unit, students will be able to:

Radiopharmacy (10 credits)

Discuss the UK regulatory requirements which apply to the design and operation of radiopharmacies and the different possible solutions to these requirements.
Recognise the different types of radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use
Describe the types of activities normally undertaken in a hospital radiopharmacy.
Describe the ways in which radiopharmaceuticals are prepared.
Discuss the general principles of QA in everyday life and in hospital pharmacy in particular including the most important means of control of aseptic preparation.
Describe how the principles of Quality Assurance are routinely applied in a radiopharmaceutical production system.
Explain the nomenclature, principles, and mechanisms of atomic reactions
Describe the design and principles of particle accelerators and nuclear reactors and their relevance for production of radionuclides used in Nuclear Medicine.
Describe in both qualitative and quantitative terms the interactions of radiation with biological systems and discuss the relative risks of nuclear medicine procedures compared to other potentially hazardous life events.
Describe the principles of the most important types of radiation detectors used in Nuclear Medicine together with the way in which they are normally employed.
Describe the structure of the atom, the most important means of radioactive decay of unstable nuclei and the types of radiation emitted.
Recognise the radionuclides used in nuclear medicine and discuss the relationships between their physical properties, their clinical applications, and their strengths and weaknesses.
Describe the radiopharmaceutical chemistry of these radionuclides and discuss the influence of these chemical properties on the biodistribution of their radiopharmaceuticals.
List the different formulations used in nuclear medicine; describe their properties and the way in which these formulations are prepared; discuss the significance of the development of radiopharmaceutical kits and describe the function of the various reagents used therein.

Aseptics (10 credits)

Explain the principles of aseptic manipulation
Describe the principles of basic pharmaceutical microbiology
Explain the key chemical and physical reactions affecting the stability of medicinal products.
Resolve drug formulation and administration problems, particularly where they relate to the modification and optimisation.

Formulation Sciences (10 credits)

Describe the principles of pharmaceutical formulation and processing
Describe the properties of excipients and ingredients in pharmaceutical products.
Explain the factors affecting formulation, stability and preservation of pharmaceutical product
Perform mathematical calculations relevant to pharmaceutical formulation.
Describe the principles of sterilisation
Understand the criticality of final packaging

Course Unit Content

Teaching and Learning Methods

Teaching will be delivered as follows:

Radiopharmacy – 1 x 1-week block which may be either online or face to face

Formulation sciences – 1 x 4-day online block

Aseptics – 1 x 3 day online block

Plus 1 x 5 day residential block.

These will include lectures, small group discussions, workshops, role-plays and experiential tasks. There will be e-learning material available.

Assessment

A 3,000 word integrated assignment covering Radiopharmacy, Aseptics and Formulation Science. This comprises 100% of the unit mark.

Year Two

PHAR61900 Quality Control

Unit Leads: Ruth Barnes (UoM)

Credit Rating: 15 credits

Course Unit Aims

The quality control unit aims to develop students’ knowledge and understanding of the techniques used for analysis of starting materials, packaging components and finished pharmaceutical products. Students will also be given the knowledge to decide on appropriate analytical methods for specific application and tools to critically evaluate data.

Course Unit Learning Outcomes

By the end of this course, students will be able to:

Discuss the role in ensuring the safety of the patient, particularly related to the manufacture of licensed and unlicensed products and Investigational Medicinal Products.
Explain the theory and use of all pharmaceutical microbiological and analytical techniques and instruments in a pharmaceutical quality control laboratory.
Discuss the quality of medicinal products, including raw materials, licensed and unlicensed products, “specials”, Investigational Medicinal Products (IMPs), medical and surgical devices and medical gases.
Define cleanroom qualification testing requirements.
Justify the choice of, and apply statistical methods to sampling and testing.
Perform analytical method validation and equipment validation.
Interpret QC data and investigate questionable data/results.
Work within the principles and practice of instruments, equipment and methodology used in pharmacy technical services.
Critically evaluate data and investigate anomalous results.
Identify validation requirements for any changes to processes.
Project management; taking responsibility for and planning a project from beginning to end.
Selection and use of appropriate methods to find solutions.

Course Unit Content

The course content covers a wide range of analytical techniques (chemical, physical and microbiological) which are employed to test pharmaceutical products, starting materials and packaging components. Students will learn about advantages and disadvantages of these methods in order to aid their decision making when developing test specifications.

Teaching and Learning Methods

A 4 day online teaching block plus a 2 day face-to-face teaching block, including lectures workshops, practicals and online learning.

E-Learning: evidence-based learning supported by course notes, audio lectures and discussion boards

Assessment

A 3,000 word assignment This comprises 100% of the unit mark.
Portfolio This is a Pass/Fail component.

For non-chemists

Letts GCSE Questions and Answers: Chemistry. London: Letts Educational Ltd. ISBN 1-85805-647-0

PHAR61910 Aseptics Advanced

Unit Leads: Oonagh McGrath (Pharmacy Manager (PSU), Bristol) and Sue Renn (UoM):

Credit Rating: 15 credits

Course Unit Aims

The Aseptics Advanced unit builds on the background knowledge provided in the Aseptics module (Introduction to Clinical Pharmaceutical Science 2 or 2A). Students will be able to explain the function and operation of equipment and clean rooms. They will know and understand commissioning procedures and be in a position to critically evaluate monitoring data and diagnose problems.

Course Unit Learning Outcomes

By the end of this course, students will be able to:

Discuss and justify all standards, practices and quality assurance arrangements relating to aseptic preparation and dispensing of medicines and their application to patient safety and patient centred care.
Explain pharmaceutical microbiological aspects of aseptic manufacture and preparation and their application in the workplace.
Evaluate the use of clean rooms/clean air devices to the best of their design potential.
Discuss the correct commissioning procedures for a clean room environment.
Critically evaluate process and operator validations.
Explain the function and operation of monitoring equipment and the maintenance of operational records.
Interpret monitoring data and diagnose problems.
Interpret stability data to determine the shelf life of the product.
Critically evaluate a range of microbiological and physical monitoring methods.
Construct risk assessments on preparation activities.
Interpret and analyse monitoring data and diagnose problems.
Assist with clean room commissioning and routine monitoring.
Effectively utilise a range of information sources.
Demonstrate capacity for self-learning and independent thinking and to utilise problem solving skills
Demonstrate effective communication skills (verbal and written).
Be able to set priorities and link these with effective time management.
Critically evaluate their personal performance both as an individual and within a team
Demonstrate skills in working collegiately and effectively with others as a member of a team.

Course Unit Content

This unit provides students with in-depth knowledge of cleanroom facilities design and their routine maintenance requirements. The unit will explore the differences between aseptic preparation and dispensing activities and aseptic manufacture.

Teaching and Learning Methods

A 3 day online teaching block plus a 3 day face to face teaching block including lectures, workshops, practicals, online learning and site visits (where possible)

E-Learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

Assessment

A 3,000 word written assignment. This comprises 100% of the unit mark.

PHAR61920 Pharmaceutical Risk Management and the role of the QP

Unit Leads: Alison Beaney (Retired Regional QA Specialist, NE) and Richard Bateman (Director of Quality, ITH Pharma) and Sue Renn (UoM)

Credit Rating: 15 credits

Course Unit Aims

This unit develops the student’s understanding of the role and professional duties of the QP within the NHS and industry environments. The module delivers core knowledge required on the pharmaceutical law and regulations applicable to the manufacture of pharmaceuticals and provides student’s with an appreciation of the process required to become a registered QP in the UK.

Students learn the skill to apply all the elements of the QP study guide in their workplace. With sufficient practical experience after the unit students should have the skills to be assessed for formal QP status.

The module will provide students with the core knowledge to identify, assess and mange risks within the pharmacy technical environment and to carry out quality assurance audits of services and service providers within this field. The module will incorporate the relevant national standards and legislation that apply within this area of practice and introduce them to the use of common risk management tools and strategies used in pharmaceutical environments.

Course Unit Learning Outcomes

Demonstrate and in-depth knowledge of the role and professional duties of the Qualified Person as defined by EU law.
Interpret the current pharmaceutical law and regulations and apply them to the manufacture of pharmaceuticals.
Apply the extensive body of knowledge required by the QP to the workplace.
Critically analyse processes and systems to assure the quality of pharmaceuticals and maintain patient safety.
Undertake a proactive approach in applying the theory of risk management to patient care
Demonstrate a working knowledge of the relevant standards and legislation required for risk management
Critically evaluate compliance with national standards using the audit and risk assessment processes
Demonstrate the skills and in-depth knowledge required to design and conduct audit and implement action plans
Follow regulatory standards and guidance.
Critically review processes and procedures during audit.
Carry out thorough risk assessments using a variety of tools and techniques.
Identifying different types of risk.
Suggesting and implementing risk reduction measures.
Applying statistical methods to determine robustness or validity of data.
Use effective negotiation skills.
Communicate difficult decisions.
Maintain a pragmatic approach during challenging debates.

Course Unit Content

This unit will provide students with the working knowledge of risk management principles and tools. It will also equip students with the core knowledge with respect to becoming a registered QP.

Teaching and Learning Methods

A 3 day online teaching block plus a 1 day face-to-face teaching block, including lectures, workshops, online learning and practicals.

E-Learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

Assessment

A 3,000 word written assignment. This comprises 100% of the unit mark.

PHAR61930 Pharmaceutical Medical Gas Testing

Unit Lead: Teresa Hughes (Principal QA Pharmacist, Royal Berkshire Hospital) and Ruth Barnes (UoM)

Credit Rating: 15 credits

Course Unit Aims

This unit develops the student’s knowledge of medical gas systems including structure and components of the relevant COSHH and Health and Safety regulations required to practice in this field. The unit will provide in-depth working knowledge of the chemical and physical properties of testing for contaminants in medical gas systems, with particular reference to the role of the Medical Gas expert in patient safety and care.

Course Unit Learning Outcomes

Demonstrate an in-depth knowledge of relevant pharmacopoeial monographs, HTM 02 and permit to work relating to medical gases.
Demonstrate a knowledge of health and safety relating to medical gases.
Demonstrate a knowledge of medical gases production and properties, and the application of GMP to medical gas production.
Demonstrate an in-depth knowledge of medical gas testing equipment including the calibration, maintenance and use in patient care.
Interpret test results of medical gas systems and take appropriate actions
Critically evaluate working practices and apply national standards.
Evaluate and advise on the safe use and management of medical gases and medical gas cylinders.
Critically appraise installations
Analyse and interpret results.
Evaluate findings and make recommendations.
Apply advanced skill in analysis of:
Oxygen
Water
Nitrous oxide
Compressed air and oxygen concentrators
Contaminants
Identify test requirements for new installations and ofr routine testing.
Determine cause/fault in defective systems
Effective communication with a multi-disciplinary team.
Efficient working under pressure.

Course Unit Content

This unit provides students with the knowledge and expertise to advise on required works and perform medical gas testing using a range of equipment and methodology. Students will appreciate the content of the Health Technical Memorandum applicable to gas testing.

Teaching and Learning Methods

A teaching block including workshops and practicals.

The teaching component is provided by Leeds CPD, Faculty of Engineering and is delivered by experts in their field.

E-Learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

Assessment

A 3,000 word written assignment This comprises 100% of the unit mark.
Portfolio. This is a Pass/Fail component.

PHAR72090 Clinical Trials

Unit Lead: Sue Renn (UoM)

Credit Rating: 15 credits

Course Unit Aims

The unit aims to enable students to:

Acquire and develop an advanced knowledge and in-depth understanding of the delivery of clinical trials in the specific settings of the NHS and the Clinical Research Organisation/Clinical Trials Unit.
Acquire and develop the advanced skills to make an effective contribution to managing clinical trials.
Demonstrate the ability to work in clinical trial practice to ensure the delivery of high quality services that meet national and international regulatory standards.
Identify their own learning needs, develop themselves as critically reflective practitioners and advance their own learning to sustain continuing professional development, and work at the forefront of clinical trial practice.
Critically evaluate literature, theories and methodologies and apply regulatory founded approaches to clinical trial delivery.

Course Unit Learning Objectives

Demonstrate an advanced knowledge and detailed understanding of:
The history and structure of the NHS and the role the NHS plays in research
The key national and international regulatory frameworks and legislation with specific reference to clinical trial conduct within which the NHS operates
The range of clinical trials which may take place within various NHS settings
The roles of Sponsors, Contract Research Organisations and Clinical Trials Units in clinical trial management
Study design including protocol development, risk assessment and accurate data capture
NHS finance, research funding streams and associated processes
The multidisciplinary and multi-organisational requirements for study set-up and management
Contractual obligations and responsibilities of key stakeholders
Management of NHS trials at site, including amendments, data capture, pharmacovigilance, site monitoring and the identification and management of protocol deviations and serious breaches
The importance of clinical trial project management, budgeting and quality management processes
How to close trials appropriately and publish results within a non-commercial setting
Critically analyse, evaluate and where appropriate formulate an informed opinion about:
Clinical trial management in the public sector and the differences and challenges compared to private sector clinical trials
National and international clinical research legislation and how it impacts project delivery in the NHS
The effectiveness of current systems and processes to streamline clinical trial applications, set-up and management The future of clinical research in the NHS
Analyse qualitative and quantitative data to determine their strength and validity.
Complete practical exercises to demonstrate an understanding of the application of knowledge derived from the course material
Engage in critically reflective practice as a process of continuous personal development.
The ability to critique information from a range of sources to formulate opinions
Set up and conduct clinical trials in accordance with legislative requirements, demonstrating high level knowledge on a process-driven approach
Networking with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation
The ability to assess current working practices based on knowledge and experience gained and adapt working processes as necessary
The ability to prioritise and effectively manage time to complete work by required deadlines

Course Unit Content

This unit engages the learner in a series of activities, learning exercises and reflective materials to provide them with an awareness of the effective management of clinical trials within the NHS research department, clinical trials unit and contract research organisation settings.

It builds upon the learning about the context and requirements for clinical trials in the introductory unit ‘An introduction to clinical trials’ to empower the learner to reflect on the additional challenges that will arise when delivering clinical trials in these particular practice areas.

Teaching and Learning Methods

This module is delivered entirely through distance learning. A printed manual consisting of ten chapters is issued to the student on registration and receipt of payment. Each chapter is designed to consist of 10 hours of assessed learning.

Additional learning activities are directed which, together with the assessment, require 50 hours of self-directed learning and assessment.

Assessment

3,000 words (split into 1 x 2000 word and 1 x 1000 word assignments). Each assessment is weighted at 50%.

PHAR61940 Radiopharmacy Advanced

Unit Leads: Bev Ellis (Consultant Radiopharmacist, Central Manchester University Hospitals), Victoria Gibson (Chief Radiopharmaceutical Scientist, Guys and St. Thomas’s)

Credit Rating: 15 credits

Course Unit Aims

The aim of the Radiopharmacy Advanced unit is to build on the background knowledge provided in the Radiopharmacy module (Introduction to Clinical Pharmaceutical Science 2). Students will gain an in-depth knowledge of how to operate at a much higher level within a radiopharmacy dealing with complex issues that may arise. They will also learn of novel drug development and imaging modalities.

Course Unit Learning Outcomes

Discuss the role of the Clinical Scientist in Radiopharmacy in the diagnosis and treatment of disease using radiopharmaceuticals, including the contribution to patient management and patient centred care
Discuss the regulations controlling transport of radioactive materials in the UK and describe the means taken to comply with these regulations.
Explain the mechanisms by which commonly used radiopharmaceuticals localise in their target tissues.
Describe those problems which might arise during the preparation and clinical use of radiopharmaceuticals and know how to identify and solve them where appropriate.
Describe the possibilities for interactions both desired and undesirable between radiopharmaceuticals and other medications.
Access and evaluate sources of reference information on all aspects of radiopharmaceuticals.
Describe the general principles of Positron Emission Tomography (PET) imaging and the organisation of a PET radiopharmacy and list the products most commonly used therein together with their clinical indications.
Describe the types of procedures routinely employed in hospital radiopharmacy management.
Explain the Quality Control parameters which determine the quality of radiopharmaceuticals.
Describe the analytical methods by which these parameters are measured.
Discuss the significance of the development of radionuclide generators for Nuclear Medicine, and the principles of their design and operation, describe the Molybdenum-99/Technetium-99m generator system and give examples of other generators in routine use.
Discuss the importance of radiation hygiene and safe working in radiopharmaceutical preparation.
Discuss the need for automation in radiopharmaceutical preparation and the possible ways in which this might be achieved.
Discuss the physical and chemical properties required of a therapeutic radiopharmaceutical and list the products approved for general use in Nuclear Medicine together with their clinical applications.
Describe the functions of the different cell types routinely labelled in nuclear medicine, outline the most significant points in the labelling procedures used and list the most common clinical indications for these radiopharmaceuticals.
Interpret stability data to determine the shelf life of the product.
Critically evaluate a range of microbiological and physical monitoring methods.
Critically appraise the impact of the radiopharmaceutical production process on the quality of clinical outcomes.
Work safely in the radiation environment.
Perform a range of radiopharmaceuticals.
Perform radiochemical purity testing on a range of radiopharmaceuticals and interpret results
Interpret and analyse monitoring data and diagnose problems.
Assist with clean room commissioning and routine monitoring.
Effectively utilise a range of information sources.
Demonstrate capacity for self-learning and independent thinking and to utilise problem solving skills
Demonstrate effective communication skills (verbal and written).
Be able to set priorities and link these with effective time management.
Critically evaluate their personal performance both as an individual and within a team
Demonstrate skills in working collegiately and effectively with others as a member of a team
Show appreciation of the way in which legislation, standards and quality management interface with normal working life.

Course Unit Content

This unit will provide students with detailed knowledge of radiation safety and the regulations surrounding the transportation of radioactive materials. The unit will also investigate new, novel approaches to imaging and diagnostics.

Teaching and Learning Methods

A teaching block including workshops, practicals and site visits.

E-Learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

Assessment

3,000 word written assignment. This comprises 100% of the unit mark.

Year Three

PHAR61810 Research Project

Academic Course Unit Co-ordinator: Dr. Lynda Harris (UoM)

Practice-based Course Unit Co-ordinator: Work-based supervisor, nominated by student base on project topic

Credit Rating: 60 credits

Course Unit Aims

The unit aims to provide students with a unique experience of designing and proposing an original research project. It will develop the students’ ability to critically appraise published research, formulate and work with a relevant research question, understand and apply appropriate research and data-analytic methodologies. Students will refine scientific writing and presentation skills and will demonstrate independent learning skill.

The students will conduct a piece of empirical research that either addresses a specific research question in the field of pharmaceutical sciences or involves the development and evaluation of new or existing technologies.

The students will be required to undertake a thorough systematic review of the scientific literature relevant to the project, which will be written up and form the introduction to the dissertation. The dissertation will also contain a clear and informed description of the methodologies employed and presentation and analysis of the data generated and a logical, scientifically valid and robust discussion of the findings.

Students will be equipped with the skills to design and develop research proposals to constantly improve and develop pharmaceutical sciences.

Course Unit Learning Outcomes

Carry out a literature search in the topic area
Synthesise and critically analyse the literature to inform the research project design
Demonstrate an ability to design an appropriate research experiment.
Employ appropriate techniques and methods to answer the research question
Critically analyse data from and if appropriate, apply statistical analytical techniques to the data.
Understand the limitations of the methods used.
Critically review the data gathered and the literature to form a conclusion answering the research question.
Present the results in both written and oral forms
Discuss the stages of the research and innovation process from conceptualisation to dissemination and if appropriate translation into practice
Critically demonstrate considerable in-depth skills in terms of research; critical thinking; reasoning; and analysis and synthesis of information.
Generate timely and theoretically grounded research questions.
Critically analyse, evaluate and interpret data from the specific enquiry.
Apply appropriate and relevant statistical tools.
Design, plan and undertake a research project to test a hypothesis from conception to completion/archiving in accordance with ethical and research governance regulations drawing on expert advice where necessary and involving patients and service users.
Plan and conduct a detailed, focused and current literature search
Implement and manage data collection
Conduct appropriate analytical techniques
Analyse the data using appropriate methods and statistical techniques and interpret, critically discuss and draw conclusions from the data.
Prepare a written project that describes and critically evaluates the research project clearly identifying the strengths and weaknesses.
Present a summary of the research project and outcome that conforms to the format of a typical scientific presentation at a national or international scientific meeting, responding to questions appropriately.
Prepare a summary of the research project suitable for non-specialist and lay audience.
Demonstrate independent thought
Develop self-management project skills (e.g. time management, prioritisation of tasks)
In-depth and extensive capabilities in the analysis and synthesis of new and past evidence on the topic, as demonstrated and applied to their area of research
Engage in systematic and critical reflection of personal practice and the practice of others in relation to the enquiry.

Course Unit Content

This unit will develop students’ ability to undertake research and scientific review.

Teaching and Learning Methods

Students carry out their research project in their place of work and each has an approved supervisor who they are expected to meet each month over the period of the dissertation. The remainder of the time is spent carrying out the literature search, developing a method and doing the research finally presenting their results both orally and as a 10,000-15,000 word dissertation.

Students are supported by the Module Leader and the Module Director throughout the module via telephone, emails and visits where possible. The academic supervisor is the Module Leader for all students undertaking this module and the students have personal support from the Programme Manager during this module. In addition all students have a work-based tutor who offers them subject specific advice and personal support.

The students are distance learners and need to be removed from their workplace to attend lectures at the University, as many are great distances from the University and contact time is limited the students cannot undertake the research methods module; therefore students attend a two day induction at the University where they have lectures on research methods from academic experts, in addition supporting materials are placed on the VLE and students can seek one-to-one advice from the Module Leader on their specific research methods.

All students prior to registration on the module must submission a draft proposal for project. This is discussed and refined at the residential study days. Following that, the final project title and abstract is submitted and approved by the Module Director. All then have the centre in which they work accredited which must have access to library facilities.

There is then a mid-project review study day followed by a mid-project report. These are not assessed but are scrutinised. Students are sent emails about the deadline for submission of the written dissertation and associated documents which are:

Progress Review Form

Evaluation Forms and

Declaration of Academic Integrity

Assessment

10,000 – 15,000 word dissertation. This comprises 100% of the unit mark.
1000 word project proposal. This is a pass/fail assessment.
15 minute presentation.

Section C: Information about the Division and University

Divisional Administration Contacts

Head of Division: Prof. Jayne Lawrence

Head of Student Operations: Gabrielle Brennan

The School address is:	Contact details:
Division of Pharmacy and Optometry The University of Manchester Stopford Building Oxford Road Manchester M13 9PT	Telephone number: 0161 306 4293 Switchboard: 0161 275 2000

* To access Stopford Building you will need a University of Manchester ID card. To obtain your student card, please contact the Student Services Centre (+44 (0)161 275 5000 / ssc@manchester.ac.uk).

Administrative contacts:

Emma Sturgess, Postgraduate Programmes Manager
(Tel: 0161 306 0259 email: emma.chaplin@manchester.ac.uk)
Postgraduate Programmes Support Team
(Tel: 0161 306 0597 email: ptqa.stp@manchester.ac.uk)

Academic staff:

Ruth Barnes, Programme Director (ruth.barnes@manchester.ac.uk)
Sue Renn, Deputy Programme Director (sue.renn@manchester.ac.uk)
Emma Davies, Lecturer in Pharmaceutical Science (emma.davies-9@manchester.ac.uk)

Student Centre

The online student support system, MyManchester enables students to register online and have access to their personal and academic details.

This means that you will be able to use the system to check and update your address and contact details, view your supervisor and advisor details and check the course units you are enrolled on. To access MyManchester, you will use the same log-in you were provided with at registration and log in to the system from the following page:

www.manchester.ac.uk/selfservice

You should use MyManchester to check we have the correct details for you and that you are on the correct programme for your intended award. You should also ensure that as soon as your contact details change that you update them on the system as well as informing the Programmes Support Team.

Progress Committee

The MSc Programme Board, and ultimately the Pharmacy and Vision Sciences Postgraduate Teaching and Learning Committee, considers issues of poor student progress, student dissatisfaction with academic supervision and other mitigating circumstances that may be influencing progress.

Failure to submit progress forms or assessments on time will result in investigation.

Communication with Students

Please note that only Blackboard, the University e-learning platform, and your allocated student university email address will be used as official communication by University staff. It is your responsibility to ensure that you can access and read email from this source.

Students are required to keep the University informed of any change to their personal circumstances such as change of name or address. Changes can be recorded by the student via their own personal online record, accessed via the MyManchester portal. It is also essential to inform the Programme Administrator if you do not intend to return to the next session of the course, if, for example, you are moving away.

Working with your own computer

Most students have their own computers, and should check that their system is compatible with the University’s. This will help avoid problems when you try to transfer documents from your machine to ours.

If using computers at work please ensure that firewalls do not block access to any of the University systems.

If you are thinking of buying a computer check the Purchasing page on the IT Services website: http://www.itservices.manchester.ac.uk/ourservices/popular/purchasing/personal/

IT Services Support Centre online

Details of what IT support is available and how to access it can be found on the FBMH eLearning Support page.

Telephone: +44 (0)161 306 5544 (or extension 65544). Telephone support is available 24 hours a day, seven days a week.

In person: Walk-up help and support is available at the Joule Library, Main Library or Alan Gilbert Learning Commons.

Use Support Centre online for support with eLearning, from where you may make a request, report a fault, or search the Knowledge Base.

For IT and eLearning support visit: https://handbooks.bmh.manchester.ac.uk/student/technical-support/

Blackboard

Blackboard (the University’s virtual learning environment) is available to students, and is accessed via https://my.manchester.ac.uk/.

All course-related materials will be placed on Blackboard so it is essential that you familiarise yourself with the system as soon as possible. Blackboard also offers Discussion forums which you may find a useful resource to share information about assignments and other course-related queries.

What is Blackboard?

Blackboard is a web-based system that complements and builds upon traditional learning methods used at The University of Manchester. By using Blackboard you can

view course materials and learning resources,
communicate with lectures and other students,
collaborate in groups,
get feedback
submit assignments
monitoring your own progress at a time and place of your own convenience.

Training in the use of software

The Faculty eLearning team have produced a short introduction to Blackboard for new students. The recording is hosted in two places: the VLS and on YouTube:

https://video.manchester.ac.uk/faculties/52f9b4cd447aa2fbeb47d1926186f80b/46971601-1356-43e2-8e78-e9f8997821f0/
https://youtu.be/47pA877MKJg

The recording is just over seven minutes long and covers most of the commonly used tools in Blackboard.

Library facilities

The University of Manchester Library provides resources and support for your Division of Pharmacy and Optometry PGT programme. The Library has an extensive collection of eBooks, databases and journals online, in addition to the print holdings in The Main Library. The Alan Gilbert Learning Commons provides a 24/7 learning environment in addition to study skills workshops.

Off-campus, many resources are available by logging in with your University username and password (this includes individual book chapters digitised as part of a unit’s directed reading); where this option is not available, the material can still be accessed through the University’s VPN service, and this is clearly indicated in the Electronic Journals A-Z list and on the information page for each of the Databases . A small number of titles require a Special username and password . For further details, see Accessing e-journals, e-books and databases.

Training materials to help you make the most of the Library’s resources will be available in Blackboard.

The My Library tab in My Manchester has quick links to get you started:

A-Z of subjects includes a library guide for Pharmacy
Library search enables you to search the Library’s electronic and physical resources – books, journals, articles, images, manuscripts, video – using a single search box
training sessions listed in the My Learning Essentials Calendar
online enquiry form
your Library Account, including PIN
Document Supply for the DELIVER postal loans service (£5 per item)

Using other libraries has information on both regional (NOWAL) and national (SCONUL) schemes which may be helpful.

Student Support

There are several options for support. The Programme Support Team is likely to be able to direct you to the most suitable support. Contact: ptqa.stp@manchester.ac.uk.

You can talk through with you issues such as interrupting your studies and progression, financial issues, the submission of details of mitigating circumstances, work and attendance problems and any personal concerns that are affecting your ability to study and engage fully with your course. It is important to point out that this is not a counselling service; it is a practical problem solving service (a confidential Counselling Service is available to all students – see the following sections for details).

Further details about student support are available on the following website:

www.studentsupport.manchester.ac.uk

Disability Advisory and Support Service

The University of Manchester welcomes students with a disability or specific learning difficulties. The University has a Disability Advisory and Support Service (DASS), who can supply further information, and staff will be pleased to meet you, by prior arrangement, to discuss your needs. Staff will liaise with your School to make the necessary arrangements for your support during your time in Manchester. DASS can also provide a copy of the University’s Disability Statement, ‘Opportunities for Students with Additional Support Needs at the University of Manchester’ which sets out the policy and provision for students with a disability.

DASS is located on the 2nd Floor of University Place, Block 2.

Contact

E-mail: dass@manchester.ac.uk
Phone 0161 275 7512/8518; Text 07899 658 790; Minicom 0161 275 2794;
Fax: 0161 275 7018; Website: http://www.dass.manchester.ac.uk/

In addition, the School has a Disability Support Officer: Sandra Humphries.

Counselling Service

The counselling service is available for all students. It is free and consists of a team of professional counsellors. The service provides confidential counselling for anyone who wants help with personal problems affecting their work or well-being.

The service is open 9.00am to 5.00pm Monday to Friday all year round except public holidays.

http://www.studentnet.manchester.ac.uk/counselling/

Occupational Health

Occupational Health is a specialised area of medicine concerned with the way in which an individual’s health can affect his or her ability to do a job and to study and conversely how the work environment can affect an individual’s health. Their aim is to promote the physical, mental and social well-being of students and to reduce the incidence of ill-health arising from exposure to work place hazards.

http://www.occhealth.manchester.ac.uk/

Students Union Advice Service

The Students Union has advisers who can help with any matter ranging from finances to housing and beyond. To contact the UMSU Advice Service please email advice.umsu@manchester.ac.uk

The Students Union website can be accessed here:
http://manchesterstudentsunion.com/

Health and Safety

See Introductory Courses.

Section D: University Regulations

Academic Support Policies

A list of University Policies and documents can be found at:

http://documents.manchester.ac.uk/list.aspx

Academic Appeals (Regulation XIX)
http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=187

Academic Malpractice: Procedure for the Handling of Cases
http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=639

Basic Guide to Student Complaints
http://documents.manchester.ac.uk/display.aspx?DocID=23875

Conduct and Discipline of Students (Regulations XVII)
http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=6530

General University information on the Conduct and Discipline of Students can be found at www.tlso.manchester.ac.uk/appeals-complaints/conductanddisciplineofstudents/.

Faculty policies for students on Communication and Dress Code, Social Networking and Drugs & Alcohol can be found at:

http://documents.manchester.ac.uk/display.aspx?DocID=29038 (Communication and Dress Code)

http://documents.manchester.ac.uk/display.aspx?DocID=29039 (Drugs & Alcohol)

http://documents.manchester.ac.uk/display.aspx?DocID=29040 (Social Networking)

Data Protection
http://www.manchester.ac.uk/aboutus/documents/privacy/

Guidance for the Presentation of Taught Masters Dissertations
http://www.regulations.manchester.ac.uk/academic/presentation-dissertations/

Policy on Submission of Work for Summative Assessment on Taught Programmes
http://documents.manchester.ac.uk/display.aspx?DocID=24561

Policy on Mitigating Circumstances
http://documents.manchester.ac.uk/display.aspx?DocID=4271

Mitigating Circumstances Guidance for Students
http://documents.manchester.ac.uk/display.aspx?DocID=23886

PGT Degree Regulations
http://documents.manchester.ac.uk/display.aspx?DocID=29208

Policy on Feedback to Undergraduate and Postgraduate Taught Students
http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=6518

Policy on religious observance for students (for UG/PGT and PGR students)
http://www.regulations.manchester.ac.uk/academic/policy-on-religious-observance/

The Faculty of Biology, Medicine and Health has produced guidance for healthcare students on fasting and caring:

https://documents.manchester.ac.uk/display.aspx?DocID=46920

Student Complaints Procedure
http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=1893

Student Charter
http://www.studentnet.manchester.ac.uk/enhancing-my-experience/charter

Work and Attendance of Students (Regulation XX)
http://documents.manchester.ac.uk/display.aspx?DocID=1895

Student Support Issues

www.studentsupport.manchester.ac.uk

A-Z of Student Services
http://www.studentnet.manchester.ac.uk/crucial-guide/

Accommodation
http://www.accommodation.manchester.ac.uk/

Blackboard
Students should access Blackboard via my Manchester at https://my.manchester.ac.uk

Careers Service
http://www.careers.manchester.ac.uk/

Counselling Service
https://www.counsellingservice.manchester.ac.uk/

Disability Advisory and Support Service
http://www.dass.manchester.ac.uk/

University Language Centre – Study English – Tel: 0161 306 3397
http://www.languagecentre.manchester.ac.uk/study-english/

Equality, Diversity and Inclusion for Staff and Students
http://www.manchester.ac.uk/aboutus/equalityanddiversity/

Health & Fitness
http://www.sport.manchester.ac.uk/

Health & Safety Policy
http://documents.manchester.ac.uk/display.aspx?DocID=654

International Advice Team
http://www.manchester.ac.uk/international/support/advice/

IT and eLearning Support
https://handbooks.bmh.manchester.ac.uk/student/technical-support/

Mature Students Guide
http://documents.manchester.ac.uk/display.aspx?DocID=18122

Occupational Health Services for Students
http://www.occhealth.manchester.ac.uk/postgraduates/

Personal Development Planning
http://www.tlso.manchester.ac.uk/personaldevelopmentplanning/

A Personal Safety Guide for International Students
http://www.studentnet.manchester.ac.uk/medialibrary/study/safety-international-student-guide.pdf

Students Union
http://manchesterstudentsunion.com/