MSc MODEL-BASED DRUG DEVELOPMENT

PROGRAMME HANDBOOK

2023/24

https://handbooks.bmh.manchester.ac.uk/2023-24/shs/pg/msc-model-based-…handbook-2023-24

Division of Pharmacy and Optometry

School of Health Sciences

Faculty of Biology, Medicine and Health

 

Welcome from the School Director of Education

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.

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.

Faculty of Biology, Medicine and Health Online Skills Training Resource

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 two units that cover introductions to study design and dissertation skills. It has a number of online quizzes where you can test your knowledge.
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.
Qualitative Research Methods*	This unit has been designed to give you an introduction to Qualitative Research.

* 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.

Guidance for the presentation of Taught Masters dissertation

The University of Manchester guidance on presentation of taught Masters Dissertations is available at:
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.

Welcome to the Programme

MSc Model-based Drug Development

Welcome to the Model-based Drug Development postgraduate programme.

This student handbook provides details of the University of Manchester Programme leading to the MSc in Model-based Drug Development and the Diploma/Certificate (exit awards). As you will notice, much of the handbook presents general information about postgraduate study at this University and within this Faculty (Biology, Medicine and Health). It is important for you to be aware of the general support and resources that the University provides. You also need to be aware of the University regulations (such as those related to “acceptable use of computers”, academic integrity, and policies on late work, sickness, and much more).

It is in Sections A and B, below, where you will find information about this particular course, including the aims and learning outcomes, structure, content, admissions, assessment and programme management.

Please make yourself familiar with the content, and keep this handbook for future reference. We hope you will find it a useful resource as you progress through the course. If anything remains unclear, please don’t hesitate to ask me or my colleagues for more information or advice.

Section A is a summary of how the course is structured.

Section B is a description of each of the course units.

Section C contains practical information about the School.

Section D lists the various University Regulations.

The students enrolled in this course bring a great range of experience into the programme. Some of you may already have a PhD or years of experience in industry or research. Others will have recently completed an undergraduate degree in a relevant area. Some of you will have detailed knowledge of analytical biochemistry or pharmacology; others will be more knowledgeable about statistical methods or data science and mathematical models. 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. Above all, we aim to provide a structure that allows you to develop and demonstrate your ability to provide intelligent guidance to the drug development process.

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 anything not answered within the handbook please do not hesitate to contact us.

We hope that your time here in 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/

Programme Director:

Kayode Ogungbenro, PhD
Division of Pharmacy and Optometry
Stopford Building, Room 3.123
Email: kayode.ogungbenro @manchester.ac.uk

School Administrative Teams:

Student Hub: shs.hub@manchester.ac.uk
Wellbeing: shs.wellbeing@manchester.ac.uk
Attendance monitoring: shs.attendance@manchester.ac.uk
Disability support: shs.dc@manchester.ac.uk
Mitigating Circumstances: shs.mitcircs@manchester.ac.uk

Programmes team: shs.programmes@manchester.ac.uk

Assessments team: shs.assessment@manchester.ac.uk

Section A: Programme Structure

Rationale and General Description

This blended learning masters course was originally designed for scientists already working within the pharmaceutical industry who wish to qualify as modellers with hands-on experience. In response to ever-increasing demand for modellers in the industry, we have developed a full-time option suitable for recent graduates who wish to begin a career related to drug development.

So we expect two categories of student.

• Type one, the Part-Time, Distance-Learning student. You are currently working for a pharmaceutical company, a regulatory authority, a contract research organisation or another research body. Your employer is supportive of your participation in the course and recognises its value for your further training and development. Ideally you will be able to identify a research project with your employer when time comes to begin your research dissertation. The distance learning aspect of the course means that you can fit your study around other commitments. However, you should also recognise that balancing your employment and academic workloads will require good self-discipline and time-management skills.
• Type two, the Full-time student in attendance at Manchester. You have completed an undergraduate degree in a scientific, mathematics or engineering discipline, and you are sure that you want to follow a career involving drug development. Ideally, you have some research or work experience that allows you to be confident that this is the right choice for you. As a full-time student in residence at Manchester, you will benefit from the resources and academic environment here. Your research dissertation will likely be carried out at the University but may involve placement with a company.

In brief, what you can expect to get out of the course:

• Familiarity with the language and common scientific/technical principles fundamental to the profession. This includes pharmacokinetic concepts (e.g., bioavailability, volume of distribution, clearance), physiological/biochemical mechanistic concepts (e.g. phase 1 metabolism, types of inhibition, Kd), statistical/mathematical concepts (e.g. covariates, goodness of fit) and clinical/legal concepts (e.g., types of trials, regulatory authorities, endpoints and biomarkers).
• Awareness of current research and state of the art of modelling and simulation for drug development, including a sense of where the technology is headed.
• Exposure to common software packages used in the industry, including hands-on experience. The extent of your experience will depend on your eventual choice of dissertation project. Note: If your main aim is to get intensive training in a particular package, such as NONMEM, you might be better advised to take one of the specialist short-courses offered by the software publishers.

 

Aims of the MSc Programme

The overall aim of the programme is to provide specialist knowledge and skills that are highly relevant for a career linked to drug development and pharmaceutical industry. The programme is designed for science, engineering or mathematics graduates who want to acquire 1) awareness of the commercial and regulatory factors in drug development, and 2) understanding of the physiological, chemical, and mathematical foundations used to define the safe and effective use of potential medicines.

The programme focuses on these key concepts:

Pharmacokinetics, addressing how a drug dose is administered to the body and the fate of drug molecules that enter the body.

Pharmacodynamics, addressing the chemical and physiological response of the body to drug.

Pharmacometrics, “the science that quantifies drug, disease and trial information to aid efficient drug development and/or regulatory decisions” (definition used by the US FDA)

Systems pharmacology, “analysis of interactions between drug and a biological system, using mathematical models and aiming to understand the behaviour of the system as a whole”

Modelling and simulation, use mathematical models to guide drug development and learn how models are improved and validated.

Specific aims of the MSc programme:

01.	Provide background information on the theory and methods for quantitative assessment of drug absorption, distribution and elimination (ADME) in the human body.
02.	Provide an understanding of the role of pharmacometrics in the process of drug development, including scientific, regulatory and commercial perspectives.
03.	Provide background information on in vitro assays used to characterise ADME properties of new drug entities.
04.	Indicate the mathematical framework (physiologically-based pharmacokinetics) that is capable of integrating in vitro information with knowledge of the human body to predict pharmacokinetics.
05.	Provide familiarity and experience of using different software platforms related to pharmacometric data analysis including R, Phoenix, NONMEM, MATLAB, Simcyp, and MONOLIX.
06.	Equip students to reflect upon influential research publications in the field, to critically assess recent published literature in a specific area.
07	Provide awareness of the elements of a convincing research proposal based on modelling and simulation, and provide practise in constructing a proposal for a novel modelling project that would add value in a specific area.
08.	Provide students an opportunity to undertake a project and carry out original research in the field of applied pharmacokinetics, pharmacodynamics and modelling and simulation.

Programme Learning Outcomes

Students will be able to:

• Display knowledge of historical development and rationale for clinical trials; drug development process; basic requirements for conducting clinical trials; ethical and regulatory aspects of the proper conduct of clinical trials
• Describe the detailed mechanisms involved in drug absorption, distribution, metabolism and excretion (ADME).
• Explain the crucial roles of pharmacometric methods in developing and gaining regulatory approval for a medicine.
• Use the biostatistical concepts and language employed in the design and interpretation of clinical data.
• Describe the details of in vitro systems used to characterise drug absorption, distribution, metabolism and excretion.
• Describe the relationships (scaling) between data obtained from in vitro systems and in vivo observations on ADME.
• Give examples of how modelling and simulation methods are currently transforming the processes of drug development and regulation.
• Evaluate the capability of different tools to perform relevant data analysis.
• Critically analyse the observations on plasma drug concentration-time profiles and characterise them quantitatively for the purpose of making inferences between different drugs, different patients, different conditions etc.
• able to design appropriate studies in delineating effects of co-variates on pharmacokinetics (including drug-drug interactions)
• Gain scholarly knowledge in a focused area of pharmacometrics, modelling and simulation.
• Deliver effective oral presentation of research findings and research proposals.
• Critically assess reports in the literature describing use of modelling and simulation to guide drug development. Identify examples of important innovations as well as examples where inconsistencies exist in the methods of analysis or representation of the outcome.
• Design and outline the details of appropriate projects to investigate including the articulation of research aims and methodology.
• Identify the reasons for differences in the time-courses of drug effect and plasma drug concentration.
• Make informed predictions of the behaviour of drugs in body with respect to plasma drug concentration-time profile.
• Make informed choices on using various models to be used for fit data obtained from studies involving Enzyme Kinetics, Pharmacokinetics, Pharmacodynamics
• Demonstrate the effective use of professional writing skills required in preparing the reports relevant to the subject area
• Execute and complete a piece of research which is narrowly focused on specific area of pharmacometric modelling and simulation.
• Debate the outcome of research and argue for validity of the methods used in the study and the conclusions drawn from the results.

A copy of the programme specification is available on the MBDD Virtual Common Room on Blackboard.

Timetable

Please note: exam dates and deadlines for submitted work given below are approximate.

Please check Blackboard for the actual dates.

Date (week of),	Full-time and Part-time, year 1	Full-time and Part-time, year 2
25 September 2023, 6 weeks	Unit: Basic PK/PD (PHAR69921)	Unit: Introduction to clinical trials (PHAR72010)
November	Due: Report & Oral presentation	Due: Clinical Trials Coursework
November, 6 weeks	Unit: Biostatistical concepts (PHAR69931)	Unit: Physiologically-based PK &IVIVE, part 1 (basic concepts) (PHAR69922)
January 2024	Exams: Basic PKPD	Due: PBPK1 report & presentation Exams: PBPK1
February 6 weeks	Unit: Data analysis in PK, (PHAR69923) part 1	Unit: Physiologically-based PK, part 2 (advanced concepts and applications) (PHAR69932)
March		Due: PBPK2 report & presentation
March 6 weeks	Unit Data analysis in PK, part 2	Unit: Project development (PHAR69924)
May	Due: Data analysis project	Due: Project proposal report
May/June	Exam: Data analysis
May/June		Exam: PBPK2
June 14 weeks	PT only – summer break in year 1	Project
September	FT only: Due – Oral presentation
September	FT only: Due – Dissertation
December 2024	FT only: Graduation
January 2025		PT only: Due: Dissertation and oral presentation
July 2025		PT only: Graduation

 

Programme Staff

The core teaching staff on the course are listed below:

Leon Aarons, BSc, MSc, PhD

PHAR69921 Basic Pharmacokinetics & Pharmacodynamics (Unit Leader) PHAR69931 Statistical Concepts in Clinical Trials (Unit Leader) PHAR69923 Data Analysis in PK &PD PHAR69924 Project Development (Supervision and Assessment) PHAR69920 Dissertation Project (Supervision and Assessment)

Following a postdoctoral fellowship at the School of Chemistry, University of Leeds, Professor Aarons joined the staff at the University of Manchester in 1976.

His major research interests lie in the area of pharmacokinetics.  He has a general interest in the subject as a whole but has a special interest in data analysis and interpretation.  He collaborates with members of the pharmacokinetic group in Manchester and also with other scientists in industry and academia throughout Europe.  His current activities revolve around population pharmacokinetics.  People involved in the drug development process are becoming increasingly aware of the importance of studying the pharmacokinetic and pharmacodynamics of the drug in the population of interest as soon as possible.

He is a member on various committees promoting research including the United Kingdom Pharmacokinetic Discussion Group.

He is Editor Emeritus of the Journal of Pharmacokinetics and Pharmacodynamics and is a member of the editorial board of the Journal of Pharmacy and Pharmacology, the European Journal of Pharmaceutical Sciences and Pharmacology Research & Perspectives.

Kayode Ogungbenro, BPharm, PhD

Course Director PHAR69923 Data Analysis in PK &PD (Unit Leader) PHAR69924 Project Development (Unit Leader, Supervision and Assessment) PHAR69920 Dissertation Project (Unit Leader, Supervision and Assessment)

Dr Kayode Ogungbenro is a Senior Lecturer in Cancer Pharmacometrics in the Division of Pharmacy and Optometry. He is also an Honorary Clinical Scientist at the Christie NHS Foundation Trust, Manchester.

Kayode obtained his PhD in 2005 from University of Manchester; he was appointed a Research Associate in 2005 at the Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester and a Research Fellow in 2009. He was subsequently appointed a Lecturer in 2014 and a Senior Lecturer in 2020. Kayode is a member of CAPKR where his research activity is currently on population pharmacokinetic and pharmacodynamic study design and data analysis, physiologically based pharmacokinetic modelling, optimal design of population pharmacokinetic and pharmacodynamic experiments, population pharmacokinetics in special population (children) and computer aided clinical trial simulation.

Aleksandra Galetin, PhD

PHAR69922 Physiologically-based PK and In vitro – In vivo Extrapolation, part 1 PHAR69932 PBPK and IVIVE, part 2 PHAR69924 Project Development (Supervision and Assessment) PHAR69920 Dissertation Project (Supervision and Assessment)

Professor Galetin is a Professor of Translational Pharmacokinetics in the Centre for Applied Pharmacokinetic Research, School of Health Sciences, Division of Pharmacy & Optometry, University of Manchester, UK. Prof Galetin is the recipient of the 2012 ISSX European New Investigator Award and 2015 AAPS Meritorious Manuscript Award. She is appointed on the expert panels such as International Transporter Consortium (ITC) and AAPS Drug Transport Focus Group Steering Committee.

Prof Galetin has extensive experience in mechanistic in vitro characterisation of hepatic and renal transporters/metabolism, in vitro-in vivo extrapolation and development of physiologically-based pharmacokinetic (PBPK) models for prediction of transporter-mediated pharmacokinetics/drug-drug interactions in different patient population groups. She led the preparation of the ITC ‘white’ paper on the best practices in transporter in vitro kinetic studies and translational modelling. In 2016, Dr Galetin completed a sabbatical in the US FDA Office of Clinical Pharmacology where she provided expert advice on the PBPK modelling of drug-drug interactions /special populations. In addition to MPharm programme, she teaches drug disposition and pharmacokinetics on MRes in Experimental Cancer Medicine and MSc course for Independent Prescribers. She has published over 75 research papers in highly cited peer reviewed journals (H index 36) and supervised/mentored 30 PhD students and postdoctoral research associates.

Amin Rostami-Hochaghan, PharmD, PhD, FCP

PHAR69922 Physiologically-based PK and In vitro – In vivo Extrapolation, part 1 PHAR69932 PBPK and IVIVE, part 2

Amin joined the University of Manchester in December 2009 as a Professor of Systems Pharmacology at the Centre for Applied Pharmacokinetic Research in the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester.

Previously Amin held a chair in Systems Pharmacology at the University of Sheffield. He joined the University of Sheffield as Research Assistant to Professor Geoff Tucker in 1996 before progressing to Lecturer, Senior Lecturer, Reader and Full Professorship posts in 1997, 2002, 2005 and 2007, respectively.

As the Vice President of Research and Development at Simcyp Limited, Amin leads a team of over 30 scientists working on extrapolation of in vitro data on drug metabolism to predict in vivo pharmacokinetics and pharmacodynamics in “virtual patient populations”.

A decade ago, Professor Rostami founded the postgraduate course in Modelling and Simulation in Pharmacokinetics & Pharmacodynamics, which has become this current course in Model-based Drug Development.

Daniel Scotcher, PhD

Deputy programme director PHAR69922 Physiologically-based PK and In vitro – In vivo Extrapolation, part 1 (Unit Lead) PHAR69932 PBPK and IVIVE, part 2 (Unit Lead) PHAR69924 Project Development (Supervision and Assessment) PHAR69920 Dissertation Project (Supervision and Assessment)

Dr Scotcher is a Lecturer in Applied Pharmacokinetics in the Division of Pharmacy and Optometry. Dan received his PhD from University of Manchester in 2016; he then visited the US Food and Drug Administration as an ORISE research fellow, and returned to University of Manchester as a post-doc, and subsequently appointed as Lecturer in 2019.

Dan’s expertise is in quantitative translation of in vitro data to predict pharmacokinetic outcomes. He draws upon direct and collaborative research experiences with pharmaceutical industry and regulatory institutions, to understand real-world practice and problems that can be addressed using combination of in vitro and in silico research methodologies. Dan is based within the Centre for Applied Pharmacokinetic Research (CAPKR), a consortium of academic researchers at The University of Manchester and industrial pharmaceutical companies.

Dissertations

The dissertation involves working closely with your 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 in the Dissertation Handbook. The University’s Guidance for the presentation of Taught Dissertations can be found on the A-Z of Student Services. This guidance tends to change annually, so confirm the dissertation unit lead that you are using the correct version. It is useful to note that the Faculty no longer requires submission of a printed dissertation, although you may want to print and bind your own personal copy. Unlike PhD theses at the University, MSc dissertations are not routinely made “open access”. We often deal with projects involving confidential data; if that is the case with your project, you should discuss with your supervisor measures to protect confidentiality.

Supervisory Arrangements

Each student’s progress will be ultimately under the direction of the Programme Directors. At the beginning of the dissertation unit (PHAR69920) students will be provided with a list of available academic supervisors, their topic areas and potential projects. On the basis of this information, students will be encouraged to speak to individual members of staff to discuss project ideas. Students will be given a few weeks in order to select supervisors/projects/research areas of their choice. Please note: it is not always possible to allocate students to the academic supervisor of choice, but every attempt will be made to match students to a research area of their choice.

Supervisor

Each student will be supervised by an academic Supervisor within the programme and in the case of part-time students co-supervised by a work-based contact whenever possible. Supervision is governed by the University Manual of Academic Procedures, which outlines in more detail the responsibilities of the Supervisor and the Student. Briefly, the responsibilities of the Supervisor include: giving guidance about the nature of research and the standard expected; the planning of the research programme; and pointing the Student towards relevant literature and other sources of information.

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.

Advisor

Each student will also be allocated an adviser. The role of the Advisor is not in any way meant to disturb the special relationship between Student and Supervisor. However, if a student feels the need to discuss matters, whether academic or otherwise, with another person, the Adviser will be available. Such discussions can be in the absence of the Supervisor outside of the framework of the formal meetings and confidential.

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 Course Administrator
• Your Supervisor
• Your Adviser
• The Student Support Officer
• The Programme Director
• The Consortium PGT Lead (Dr Ellen Schafheutle)
• 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 student’s 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 form 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%.

 

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.

Please find below the link to the degree regulations:
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 Postgraduate Taught Degree Regulations

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

• The course unit pass mark for all levels (i.e. Postgraduate Certificate, Diploma and Masters) is 50%.
• The programme will not apply any compensation rules

Criteria of Levels of Achievement

To obtain a pass for the Postgraduate Certificate you are required to successfully pass 60 credits, Postgraduate Diploma – 120 credits, and Masters you are required to successfully pass 180 credits. You must achieve a mark of 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.

Reassessment

Where the overall unit mark is below the compensation zone (40% for Masters and 30% for Postgraduate Diploma/Certificate) OR the number of compensable fails (30 credits for Masters/Diploma and 15 credits for Postgraduate Certificate) has been exceeded, reassessment may be taken.

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 and compensated 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 40% for Postgraduate Diploma/Certificate). When a reassessment is passed, the mark is capped at the lowest compensable fail mark (i.e. 40R for Masters and 30R for Postgraduate Diploma/Certificate), 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.

Referrals may also be compensated providing the number of quota of compensations has not been exceeded. When a student’s referral mark is in the compensation zone (and the student/unit is eligible for compensation), the student’s mark will be capped at the lowest compensable fail mark (i.e. 40R for Masters and 30R for Postgraduate Diploma/Certificate).

Please note that some programmes do not allow referrals. Please refer to the ‘Programme Exemptions to PGT Degree Regulations’ section of the handbook where specific exemptions applicable to the programme will be listed.

Deadlines for Assessed Work

All assessed work must be handed in at the prescribed time. Submission deadlines are published on Blackboard. Where those dates differ from those contained herein, Blackboard should be considered authoritative. WE RECOMMEND THAT YOU TRANSFER THESE DATES TO YOUR DIARIES AS SOON AS THEY ARE PUBLISHED.

Assessment submissions

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.

All written summative assessments should be submitted via Blackboard® through SafeAssign®. All written summative assessments must be submitted anonymously, only displaying your student ID.

Submission deadline dates are published on Blackboard® for each course unit. However the submission time is always 12 noon UK local time.

We urge you to attempt to submit your assessment early in order to address any problems before the deadline.

Assessments must be submitted within the specified deadline. If there is a problem which prevents you submitting the assessment on time you must bring this to the attention of the Assessment and Progression Administrator promptly and 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 one week for circumstances such as acute illness (see the section on Extensions for full details). If you are experiencing longer term problems you should follow the mitigating circumstances route (see the section on Mitigating circumstances).

Late submission policy (including dissertations)

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 re-sit the assessment as the original mark can be taken in lieu of a re-sit/referral and normal re-sit/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

Sometimes, factors beyond your control may interfere with your ability to attend to your academic studies. The University’s mitigating circumstances procedures exist to try to mitigate against the impact that this could have on your grades.

The full mitigating circumstances policy and guidance can be accessed via the following link: https://www.studentsupport.manchester.ac.uk/study-support/mitigating-circumstances/

We strongly recommend that you seek advice from a member of the Wellbeing team before submitting any claim for mitigating circumstances. You can contact them via shs.mitcircs@manchester.ac.uk or shs.wellbeing@manchester.ac.uk

Grounds for mitigation

Grounds for mitigation are unforeseeable or unpreventable circumstances that could have, or did have, a significant adverse effect on your academic performance.

Possible mitigating circumstances include:

• significant illness or injury
• the death or critical/significant illness of a close family member/dependant
• significant family crises or major financial problems leading to acute stress
• absence for public service e.g., jury service

Circumstances that will not normally be regarded as grounds for mitigation include:

• holidays, moving house and events that were planned or could reasonably have been expected
• assessments that are scheduled close together
• misreading the timetable or misunderstanding the requirements for assessments
• inadequate planning and time management
• consequences of paid employment
• exam stress or panic attacks not diagnosed as illness or supported by medical evidence
• disruption in an examination room during the course of an assessment which has not been recorded by the invigilators

Applying for mitigation

You should inform us if you experience difficulties that may negatively affect your performance on assessed work. You can inform us of such difficulties by submitting an online Mitigating Circumstances Form. The form must be completed by you. It will ask you to provide details of your difficult circumstances and to list the assessments affected. It is important that you list each separate assessment, giving details of the course unit and the nature of the assessment (e.g. PSYC10711 Essay or PSYC10100 Week 4 Quiz). Your form should also be supported with evidence, which is independent and time-specific (for example, a doctor’s note which confirms that you were ill and indicates the period affected). Our Student Support and Wellbeing team can advise you on the information required on the form.

You should inform us of mitigating circumstances as soon as you become aware that they might affect your performance. Typically, mitigating circumstances must be submitted prior to the assessment taking place. In exceptional circumstances, where it is not possible to inform us in advance, you should submit your Mitigating Circumstances application as soon as possible after deadline or scheduled examination, supported by a credible and compelling explanation of why your claim could not be submitted in advance.

Please note, not informing the University of circumstances due to personal feelings, e.g., shame, embarrassment and pride, or having concerns over the confidential treatment of requests for mitigation, are not considered to be credible and compelling explanations as to why the circumstances could not be made known or shown by these deadlines. If the details of the mitigating circumstances are considered to be highly confidential, you can discuss with the wellbeing team shs.wellbeing@manchester.ac.uk the best way to submit an application. The committee handle all requests for mitigation with sensitivity and due regard for confidentiality.

How mitigation is considered and applied

Evidence for personal and medical mitigating circumstances is considered by a mitigating circumstances committee. It is this committee’s role to determine whether there is evidence of mitigating circumstances, whether those circumstances could have had an effect on your performance, and the likely impact. The committee will consider all submissions and, where there is evidence that circumstances have been serious enough to have an effect on one or more elements of assessment, the committee will make recommendations to the exam board.

The exam board, at the recommendation of the mitigating circumstances committee, can take a limited number of actions to apply mitigation. In most cases, acceptance of the mitigation will involve revoking any late submission penalties or allowing for the missed or failed coursework/exam to be taken again as a first sit.

A claim for mitigating circumstances may be turned down for several reasons:

• The circumstances detailed by the student are not regarded as grounds for mitigation under the Policy on Mitigating Circumstances
• The supporting evidence does not cover the relevant period
• The supporting evidence is not supplied by an appropriate (independent) source
• The supporting evidence is deemed insufficient to support the student’s claim of the seriousness of impact on their assessment performance
• The wording of the evidence supplied does not support the student’s claim e.g. the material does not provide a medical diagnosis
• No evidence is provided, and the student has not given any explanation as to the reasons why nor indicated when evidence could be available
• The evidence relates to a chronic condition which the student is already in receipt of support from the Disability Advisory and Support Service (DASS). This does not include instances where the student has an acute flare up of a pre-existing condition which may be accepted if properly evidenced and confirmed by DASS
• The deadline for submitting mitigating circumstances has been missed, without a credible and compelling reason
• The claim relates to an ongoing condition or circumstance previously used to claim mitigation where the Panel, on the earlier occasion, instructed the student that this mitigation could not be used again and may have instructed the student to access support from the Disability Advisory and Support Service

Extensions

If you experience difficulties that will prevent you from submitting assessed coursework on time, you can request an extension of up to one week.  You need to provide a credible reason for your extension, in line with the extension policy, but you do not need to submit evidence to support your request.

Please think carefully about whether one-week is enough time to submit and how this will impact the rest of your workload before requesting an extension.

To apply for an extension, you will need to complete this form:

https://www.qualtrics.manchester.ac.uk/jfe/form/SV_56LcBQhsaZ6Agsu

Extensions should be applied for by 15:00pm on the day of your original assessment submission date. Any applications after this time will not be considered and you will need to apply for mitigating circumstances.

If mitigating circumstances prevent you from submitting an extension request in advance, or mean that you miss the extended deadline that has been awarded, you should submit mitigating circumstances following the procedures outlined in the mitigating circumstances procedure. Please note, such requests for mitigation will only be considered where students provide a clear justification (including evidence) for failing to follow the normal extension request procedure.

Some DASS students are entitled to an automatic one-week extension, which does not need to be applied for. If you are a DASS student with this automatic extension and require longer than one-week, please complete the form above by 15:00pm on the day of your DASS submission date.

Word Limits for Assessed Work

In accordance with the University Policy on Marking:

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.

Word limits should not include text in the bibliography/reference list, figure legends and tables and appendices (if relevant). However, students cannot use figure legends or text within tables to try and side step the word limit (i.e. figure legends and table must be of appropriate length) and must be warned that if they do so they will be penalised.

Where assignments have high numeric content (e.g. statistics) then a judgement should be made as to whether it is reasonable for this ruling to apply.

Where any 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

All assignments must be submitted electronically via Turnitin. The published deadlines for assessments all relate to the electronic submission which is done via Blackboard, on the TurnItIn 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
  • Go to assessment folder
  • Upload your assignment via the Turnitin process http://documents.manchester.ac.uk/display.aspx?DocID=13010
  • If you have any problems accessing the student portal contact http://www.itservices.manchester.ac.uk/contacts

Please remember you can only upload 1 document so you cannot save your references as a separate document.

IMPORTANT

For Online Blackboard submissions, you MUST put your ID number first in your assignment title and save your document using your ID Number e.g. 7123456 Assignment 1. DO NOT save the work as ‘Essay’ or as the title of the work

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

The electronic copy is your official record of submission.

Turnitin System

The University uses electronic systems for the purposes of detecting plagiarism and other forms of academic malpractice and for marking.  Such systems include TurnitinUK, the plagiarism detection service used by the University. Where appropriate, summative assessed written work, including dissertations and projects, should be submitted online and subjected to plagiarism detection software.

As part of the formative and/or summative assessment process, you may be asked to submit electronic versions of your work to TurnitinUK 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 TurnitinUK 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.

Example Marking Scheme

A generalised marking scheme for examinations and assignments to give an indication of the levels required for the award of a range of marks is given below.

Classification	Mark as %	Criteria
Distinction	100 80 70	Perfect critique with outstanding degree of originality. Provides novel insights, including the ability to apply concepts to related fields Excellent, well organised critique with clear evidence of understanding. Contains examples of original ideas and supplementary reading Outstanding. Shows clear understanding of topic, examples of supplementary reading and cross-referencing of material. Very well presented.
Merit	69 60	Very good. Well structured and presented report that is able to convey the central aspects of the tutorial material. Good. Comprehensive answer with accurate facts but largely limited to material covered in the tutorial class
Pass	59 50	Adequate answer with some errors or omissions. Limited to tutorial class material.
Unacceptable	49 40	Incomplete/inadequate answer with contains relevant information but demonstrates an incomplete understanding of tutorial material Clearly incomplete/inadequate answer with sparse relevant information and poor understanding of tutorial material
Fail	39 0	Deficient answer with many inaccuracies and little evidence of understanding of the tutorial topic No relevant material presented whatsoever

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 observed assessments will be double marked. Marks awarded for your assessments (i.e. everything which contributes to your final degree classification) 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 and post out a breakdown of your marks.

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 marked 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 and going to My Services/Self Service and Student Centre. You can choose ‘Assignments’ from the drop down box and choose the relevant unit. Your Final mark for the unit doesn’t appear until the unit is fully completed and marks have been through an exam board.

Examinations

Examinations run in the standard University exam periods. 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 unit. Do not presume that because a piece of coursework has covered one area of a unit 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.

Monitoring Progress – Dissertations

In order to monitor their progress, students will have regular, scheduled meetings with their dissertation supervisor. Progress forms should be completed at these meetings. These meetings are in addition to the normal dissertation supervisory meetings between the student and supervisor, of which there should be a minimum of 12 per academic year (6 for part-time students).

In order to provide opportunity for reflection, students will be required to complete a Progress Form at each meeting with their supervisor which must be signed by both parties following the meeting. This form should be used as the basis for discussion in the meetings. After each meeting, the student will be required to submit a copy of the form to the MSc Administrator by the dates specified above, to ensure that School records are complete and up-to date.

Interruptions and Withdrawals

Interruptions

If at any point in your studies you feel that you need to take some time away from your degree, you can interrupt your studies and return once you are ready. You need to be aware of the below implications when considering taking an interruption, so it is best to discuss any queries you may have with the Student Support and Wellbeing Team/Programme Director/Year Tutor/Academic Advisor.

There are a few important things to think about when deciding to interrupt:

• Primarily, your wellbeing. If an interruption is the best decision for you, it should benefit your present and future wellbeing and support you completing your degree to the best of your abilities.
• Tuition Fees
• Accommodation (if living in UoM halls)
• Possible changes to course content on return
• Tier 4 students MUST be referred to the Student Immigration Team in SSC to discuss consequences of interruption (3.2 Policy on Interruptions to UG and PGT Programmes of Study)

If you then wish to request an interruption to study, either via email, during a welfare meeting, or following a meeting with an AA, you would need to complete an SHS Interruption Request Form, which can be obtained by contacting the Student Support and Wellbeing team on shs.wellbeing@manchester.ac.uk. It is helpful to know at this stage how long you expect to interrupt for and when you might return.

You need to complete and sign the form, returning it back to the shs.wellbeing@manchester.ac.uk email address with any appropriate supporting evidence. The form will then be sent to the relevant member of academic staff for approval (this may be the Programme Director, Year Tutor or Academic Advisor).

*Please note that students will be contacted by the Student Support and Wellbeing Team prior to their return to study/return from interruption*

Withdrawals

If you decide that you are unable to continue your programme, you can withdraw from your studies. You will need to be aware of the below implications when considering withdrawing from the programme, so we would always advise discussing any queries you may have with the Student Support and Wellbeing Team/Programme Director/Year Tutor/Academic Advisor.

• Tuition Fees
• Accommodation (if living in UoM halls)
• Future career prospects

If you then wish to withdraw from the programme, either via email, during a welfare meeting, or following a meeting with an AA, you will need to complete a SHS Withdrawal Request Form, which can be obtained by contacting the Student Support and Wellbeing team on shs.wellbeing@manchester.ac.uk

Students need to complete and sign the form, returning it back to the shs.wellbeing@manchester.ac.uk email address. No supporting evidence is required for a request to withdraw. The form will then be sent to the relevant member of academic staff for approval (this may be the Programme Director, Year Tutor or Academic Advisor)

Once the Student Support and Wellbeing Team has received the form which has been approved by the relevant member of staff, a standard confirmation letter will be sent to you confirming the details of the withdrawal.

Academic Appeals

For the most up to date information regarding appeals, students should refer to the University’s general support pages, since the pages are updated to reflect changes in policy and guidelines.

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.

Students thinking of appealing should first discuss the matter informally with an appropriate member of staff, in order to better understand the reason for the result or decision and to determine whether the matter can be resolved informally by the School prior to making a formal appeal.

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, electronically by e-mail: FBMHappealsandcomplaints@manchester.ac.uk.

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

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

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, electronically by 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 http://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)

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 and projects, 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/

The Student Support website provides guidance on Good Study Skills and on on avoiding academic malpractice:

https://www.studentsupport.manchester.ac.uk/study-support/goodstudyskills/

https://www.studentsupport.manchester.ac.uk/study-support/academic-support/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), plaExtercement and training providers and/or regulator (such as the General Pharmaceutical Council or the Royal Pharmaceutical Society)). 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 Introductory Courses.

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 your Educational Supervisor or Programme Director.

Election of a Student Representative

Each programme will choose a number of student representatives at the start of each academic year. You will be able to apply for this role, and will be informed of who is chosen so that you can feed back any issues or areas for improvement you may have identified within your programme.

The representatives are invited to the Staff Student Liaison Committee, where they can feedback anything which they have heard from their fellow students. The Programme Team then respond to these, and these responses and any action taken are fed back to staff and students via a newsletter.

Academic Advisors

Each student is assigned an Academic Advisor at the beginning of their degree. This will be a member of the academic staff in your department who can offer support and advice on academic and pastoral matters, and are key to the School’s student support structure.

You will meet with your Academic Advisor during Welcome Week, and will then have one-to-one meetings throughout the semester to discuss academic progress, steps taken towards career planning, and professional and personal development.

IAG/Hub

The Information, Advice & Guidance (IAG) team are your first point of contact for any non-academic queries you may have relating to your studies, such as what support is available to you, how to access it, and where to direct any queries which you’re not sure about. The IAG team can be contacted via email at shs.hub@manchester.ac.uk, over the phone at 0161 306 7811, or in person at the student hub which is located on the ground floor of the Jean McFarlane building.

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.

External Examiners

External Examiners 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 Examiners’ 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 Examiners’ comments will be discussed. Students should contact their student representatives if they require any further information about External Examiners’ reports or the process for considering them.

The External Examiner for this programme is: Dr Raj K. Singh Badhan
Name of Institution: Aston University
Position at current Institution: Lecturer in Pharmacokinetics (Pharmacometrics)

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

1. 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
2. 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
3. To liaise with programme administrators and lecturers to organise examining, marking and student feedback
4. To develop and monitor the Blackboard E-Learning site for their unit, in liaison with lecturers for the sessions in their unit
5. To liaise with students concerning queries relating to teaching and assessments for the unit that are not specific to an individual teaching session
6. To attend programme meetings and the programme exam board in order to liaise with programme directors and student representatives
7. 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

Roles and Responsibilities of Supervisors

1. 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);
2. maintaining contact through regular meetings (the frequency of meetings being appropriate to the research being undertaken and agreed in advance);
3. being accessible to the student at other appropriate times for advice and responding to difficulties raised by the student;
4. 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;
5. requesting written work or reports as appropriate and returning written material with constructive criticism and in reasonable time;
6. 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.
7. ensuring that the student is made aware when progress is not satisfactory and facilitating improvement with advice and guidance;
8. 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;
9. ensuring that at the end of each year of the course the student produces a research report, to which the Supervisor should add comments on progress. The Supervisor’s comments on progress should be signed by the student to confirm that they have been seen, before the annotated report is submitted by the Supervisor to the appropriate Supervisory body in accordance with established Graduate School procedures;
10. making students aware of other researchers and research work in the department and Graduate School;
11. encouraging the student to publish the research;
12. providing pastoral support and advising students, where appropriate, of University support services;
13. bringing to the attention of the students the health and safety regulations and academic rules, regulations and codes of practice of the University.

More detailed guidance on Health and Safety is available in the University’s Health and Safety Policy Notice UMHSP 33, available from Health and Safety Services, which interprets and applies the CVCP Note of Guidance N/93/111, “Health and Safety Responsibilities of Supervisors towards Graduate and Undergraduate students”. Guidance on specific situations is available from the staff of Health and Safety Services.

Responsibilities of the Student

1. 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;
2. discussing with the Supervisor the type of guidance and comment believed to be most helpful, and agreeing a schedule of meetings;
3. ensuring that he/she is aware of the health and safety regulations and academic rules and regulations and codes of practice of the University;
4. successfully completing any training programme arranged within the prescribed time period;
5. 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;
6. 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;
7. agreeing with the Supervisor the amount of time to be devoted to the research and the timing and duration of holiday periods;
8. 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

Unit Sequence	Full-time & Part-time, Year 1	Full-time & Part-time, Year2
Semester 1 (Sept-Jan)	PHAR69921 Basic PKPD; PHAR69931 Introduction to Biostatistics	PHAR72010 Intro to clinical trials; PHAR69922 Physiologically-based PKPD, part 1
Semester 2 (Feb-May)	PHAR69923 Data analysis in PKPD	PHAR69932 Physiologically-based PKPD, part 2 PHAR69924 Project preparation
Summer FT: June-Sept of Year 1, PT: June–Jan of Year 2		PHAR69920 (Dissertation)

Course Units

Study Method & Unit content

For each unit there is a unit description outlining what is required, these are listed below. Throughout your studies help and support is available from your Academic Advisor, the Programme Director and the PGT Programmes Support team. All elements of each unit must be undertaken in order to complete the unit, they are all compulsory components.

The unit descriptions and handbook provide an overall outline for the course, any further details or advice on specifics of the programme should be sought from the unit leader. Students are advised to keep the unit leader and administrator up to date on the progress of their study, including any difficulties they are encountering. Regular updates between the students and unit leader will also take place through a series of tutorials based on specific essays and coursework questions and these will be available to Distance-Learning students through on-line virtual meetings.

PHAR69921 Basic Pharmacokinetics and Pharmacodynamics (PKPD)

Unit Lead: Prof. Leon Aarons

This introductory unit is designed to give the student an understanding of fundamental concepts in pharmacokinetics and pharmacodynamics, essentially how drugs get into the body, how they get around the body and how they get out of the body. Topics include the processes of absorption, distribution, metabolism and excretion (ADME), the concept of compartmental analysis, and basic statistical concepts.

Emphasis is given to explaining how chemical properties of drug interact with physiological aspects of the human body to affect the behaviour of different drugs and the variation between individual patients. Quantitative assessment of the processes (modelling and data analysis) is described with reference to drug discovery, drug development and therapeutic usage. The unit also provides experience in solving numerical problems relating the time-course of drugs and their metabolites in the body.

This unit is a prerequisite for subsequent units which focus on physiologically-based models and advanced approaches to data analysis.

Theoretical knowledge will be disseminated through a series of lectures and tutored workshops. Students will then work on a structured assignment that emphasises the application of theory by solving problems.

Summary of Teaching

Lectures (15) 30 hours

Tutored workshops (6) 12 hours

Tutorial/feedback (3 to 6) 6 hours

Independent Study 90 hours
(reading, case study)

Assessment

Assignment– Case study report and oral presentation 60%

Formal Examination (January exam period) 40%

Learning Outcomes

Knowledge:

• Describe the detailed mechanisms involved in drug absorption, distribution, metabolism and excretion (ADME).
• Explain the crucial roles of pharmacometric methods in developing and gaining regulatory approval for a medicine, and specifically the role of pharmacokinetics and biostatistics in guiding the design and conduct of clinical trials.

Skills:

• Make informed predictions on the influence of any change in (ADME) mechanism on plasma drug concentration-time profile for a given substance,
• Critically analyse observations on plasma drug concentration-time profiles and characterise them quantitatively for the purpose of making inferences between different drugs, different patients, different conditions etc.
• Identify the reasons for differences in the time-courses of drug effect and plasma drug concentration.
• Apply basic biostatistical concepts and interpret statistical information arising from clinical trials.

Transferable Skills:

• Perform calculations using fundamental pharmacokinetic equations
• Produce written reports on the pharmacokinetics of a given drug, making effective use of pharmacokinetic terminology.

PHAR69922 In Vitro- In Vivo Extrapolation (IVIVE) of ADME & Physiologically- Based Pharmacokinetics [PBPK1]

Unit Lead – Dr Dan Scotcher

This unit provides a focused introduction to the use of mechanistic pharmacokinetic models, which use mathematical descriptions of physiological processes to predict the fate of drug molecules within the human body. Therefore, the unit addresses two key aspects of IVIVE: 1) developing mathematical representation of key chemical and physiological processes that affect drug molecules in the body, and 2) defining the relationships that link these processes. Implementation of this approach will be described in the following areas:

• Prediction of drug-drug interactions by extrapolating from in vitro laboratory tests before commencing clinical studies
• Prediction of oral absorption; guiding the design of oral drug formulations

Topics outline

Introduction to physiologically-based pharmacokinetics (PBPK) and systems pharmacology

Modelling of in vitro experiments

• metabolic assays
• permeability
• mDDI assay data
• transporter/transporter-metabolic DDI assay

Quantitative prediction and IVIVE of metabolic clearance

• Physiology of hepatic and extrahepatic metabolism
• In vitro-in vivo extrapolation (IVIVE) of metabolism
• PBPK modelling and simulation (M&S)
• IVIVE in drug development

Predicting absorption

• Principles of drug absorption
• The evolution of PBPK absorption models
• PBPK M&S of oral formulation effects
• PBPK M&S in drug and formulation development
• PBPK M&S of food effects
• dermal absorption; pulmonary absorption

Drug distribution and binding

• Principles of drug distribution
• Models for predicting volume of distribution
• Whole-body PBPK M&S
• Drug binding and local tissue concentrations

Summary of Teaching

Lectures [16] 16 h

Seminars (Webinars) [7] 14 h

Hands-on workshops [15] 30 h

Independent Study 90 h

Assessment

Final exam 40%

Coursework, Case Study report and presentation 60%

Knowledge:

• Describe the details of in vitro systems used to characterise drug absorption, distribution, metabolism and excretion.
• Describe the relationships (scaling) between data obtained from in vitro systems and in vivo observations on ADME.

Skills:

• Critically analyse observations on plasma drug concentration-time profiles and characterise them quantitatively for the purpose of making inferences between different drugs, different patients, different conditions etc.
• Identify the reasons for differences in the time-courses of drug effect and plasma drug concentration.
• Make informed predictions of the behaviour of drugs in body with respect to plasma drug concentration-time profile.
• Apply basic biostatistical concepts and interpret statistical information arising from clinical trials.

Transferable Skills:

• extracting key points from scientific literature
• effective written communication

Suggested Reading

Lecture notes cite key research articles and reviews, which include…

Wienkers, L.C. and T.G. Heath (2005) Predicting in vivo drug interactions from in vitro drug discovery data. Nat Rev Drug Discov 4:825-33.

Houston, J.B. and A. Galetin (2008) Methods for predicting in vivo pharmacokinetics using data from in vitro assays. Curr Drug Metab. 9:940-51.

Rostami-Hodjegan, A. (2012) Physiologically Based Pharmacokinetics Joined With In Vitro-In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology. Clin Pharmacol Ther 92:50-61.

Jamei, M., S. Marciniak, K. Feng, A. Barnett, G. Tucker, and A. Rostami-Hodjegan (2009) The Simcyp population-based ADME simulator. Expert Opin Drug Metab Toxicol. 5:211-23.

Rowland, M., C. Peck, and G. Tucker (2011) Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol 51:45-73.

Zhao, P., M. Rowland, and S.M. Huang (2012) Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin Pharmacol Ther 92:17-20.

Tsamandouras, N., A. Rostami-Hodjegan, and L. Aarons (2013) Combining the “bottom-up” and “top-down” approaches in pharmacokinetic modelling: Fitting PBPK models to observed clinical data. Br J Clin Pharmacol.

PHAR69932 Advanced topics in Physiologically-based PK models [PBPK2]

Unit Lead: Dr Dan Scotcher

This unit provides further training on the use of mechanistic pharmacokinetic models, which use mathematical descriptions of physiological processes to predict the fate of drug molecules within the human body. Completion of the introductory unit is an essential prerequisite. The unit addresses two key aspects of IVIVE: 1) developing mathematical representation of key chemical and physiological processes that affect drug molecules in the body, and 2) defining the relationships that link these processes. Implementation of this approach will be described in the following areas: Prediction of drug-drug and drug-disease interactions in special populations such as neonates, children, patients with kidney or liver impairment Use of IVIVE to assess propagation of genetic differences in drug metabolizing enzymes in different populations Special considerations for biologics Topics outline Interspecies extrapolation and first-in-human (FIH) design Principles of interspecies extrapolation and scaling to human PBPK modelling and simulation between species PBPK modelling to determine FIH dosing Metabolite kinetics PBPK modelling of parent-metabolite pharmacokinetics mDDIs – PBPK M&S to inform drug labelling and clinical care Principles of metabolic drug-drug interactions (mDDIs): competitive inhibition, mechanism-based inhibition and induction IVIVE of metabolic mDDIs PBPK modelling of mDDIs Complex drug interactions Transporter DDIs IVIVE of complex DDIs Drug-disease interactions PBPK modelling and simulation of complex drug interactions Special populations – PBPK modelling in special disease populations – renal failure and hepatic impairment PBPK modelling in special subpopulations – Paediatrics, pregnancy and obesity PBPK M&S of biologics Coupling PBPK M&S with pharmacodynamic (PD) modelling

Summary of Teaching

Lectures 15 h

Seminars (Webinars) 14 h

Hands-on workshops 30 h

Independent Study 90 h

Assessment

Final exam 40%

Coursework, Case Study report and presentation 60%

Suggested Reading

Wienkers, L.C. and T.G. Heath (2005) Predicting in vivo drug interactions from in vitro drug discovery data. Nat Rev Drug Discov 4:825-33.

Houston, J.B. and A. Galetin (2008) Methods for predicting in vivo pharmacokinetics using data from in vitro assays. Curr Drug Metab. 9:940-51.

Rostami-Hodjegan, A. (2012) Physiologically Based Pharmacokinetics Joined With In Vitro-In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology. Clin Pharmacol Ther 92:50-61.

Jamei, M., S. Marciniak, K. Feng, A. Barnett, G. Tucker, and A. Rostami-Hodjegan (2009) The Simcyp population-based ADME simulator. Expert Opin Drug Metab Toxicol. 5:211-23.

Rowland, M., C. Peck, and G. Tucker (2011) Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol 51:45-73.

Zhao, P., M. Rowland, and S.M. Huang (2012) Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin Pharmacol Ther 92:17-20.

Tsamandouras, N., A. Rostami-Hodjegan, and L. Aarons (2013) Combining the “bottom-up” and “top-down” approaches in pharmacokinetic modelling: Fitting PBPK models to observed clinical data. Br J Clin Pharmacol.

PHAR69923 Data Analysis in PKPD

Unit Lead: Dr. Kayode Ogungbenro

This is a taught unit which covers data analysis in PKPD studies. This is a specialised area of modelling that combines mathematical and statistical knowledge in data fitting with a sound knowledge of the human body as a system in order to choose more mechanistic models. Analyses can describe the observed data but can also be used for the purpose of prediction. The mathematical background provided in this unit relates to linear and non-linear fitting, optimisation procedures that are applied to objective function(s) and optimal design issues. Statistical input relates to finding inferences, covariates and application of non-linear mixed effect modelling amongst other subjects. This unit also provides information on available tools for data analysis and their applications. Most commonly used platforms for data analysis such as Phoenix, Monolix, nlmixr, and NONMEM are part of the unit where students analyse data with a number of different packages and learn their advantages and disadvantages.

Summary of Teaching

Lectures (15L x 2H) = 30 h

Seminars (Webinars) (6W x 2H) = 12 h

Tutorials (12T x 2H) = 24 h

Assignment/Problem Solving (4P x 45H) = 180 h

Independent Study (10P x 12H) = 45 h

KEY:

W = Week; D = Day; L= Lecture; T= Tutorial; P = Problem Solving Assignment; H = Hour

Assessment

Examination (end of year 1) 40%

Coursework (4 equally weighted assignments) 60%

Learning Outcomes

Knowledge:

• Evaluate the use of different software packages to perform certain types of data analysis

Skills:

• Understand the different types of models that exist in PK and PD
• Understand basic concepts and mathematical principles associated with parameter estimation in pharmacokinetic (PK) and pharmacodynamics (PD) modelling
• Implement basic models in PK and PD for estimation and simulation purposes
• Understand how to choose between the different software packages available for parameter estimation depending on the situation in PK and PD
• Interpret results obtained from different software packages in PK and PD

Transferable Skills:

• Critically assess published reports in the field of Pharmacometrics for consistency in use of methods and other assumptions

PHAR69931 Introduction to Biostatistics

Unit Lead: Prof. Leon Aarons

This unit is designed to give the student an understanding of fundamental statistical concepts that are routinely used in designing clinical trials or interpreting trial results.

Emphasis is given to the use of simple hands-on exercises to build confidence in the application of concepts and in the practical use of software for statistical problem solving.

This unit is a prerequisite for the subsequent unit (PHAR69923) on advanced approaches to data analysis, including mixed effects models and population pharmacokinetics.

Theoretical knowledge will be disseminated first by lecture, but the unit will emphasise the application of theory by solving problems in workshops and coursework assignments. Some of the assignments will be computer based, to ensure students are comfortable with basic software for data analysis and presentation before encountering more specialised software in subsequent units.

Students will complete exercises using Microsoft Excel, SPSS and R.

Summary of Teaching

Lecture 10h

Workshop/tutorials 20h

Academic Advisor 4h

Independent study 100h

Assessment

Biostatistics problems coursework 100%

Learning Outcomes

Knowledge

• Define and apply the statistical terms relevant to clinical trial data collection and interpretation.
• Explain the crucial role biostatistics plays in guiding the design and conduct of clinical trials.

Skills

• Apply basic biostatistical concepts and interpret statistical information arising from clinical trials.
• Understand the statistical terms presented in clinical trial documents
• Use computer software such as Excel and SPSS to perform basic computational tasks including file input/output, calculations, and production of effective graphs

Transferable skills

• Independent learning, mastering new software

Suggested reading

Senn S. Statistical Issues in Drug Development. John Wiley & Sons. Chichester. 1997

Armitage P, Berry, G, Mathews JNS. Statistical Methods in Medical Research. Blackwell Publishing, Oxford. 2002.

BMJ statistics notes. (Altman et al.)

PHAR72010 Introduction to Clinical Trials

This introductory unit provides an overview of the basic requirements and procedures employed in planning and conducting clinical trials. It also provides guidance on ethical, regulatory and statistical aspects as well as the managerial requirements.

Aims:

• Acquire and develop an advanced knowledge and in depth understanding of the theory of setting up and running clinical trials
• Acquire and develop the advanced skills to make an effective contribution to clinical trial practice
• Demonstrate the ability to analyse the different clinical trial phases and the purpose of each
• Identify their own learning needs, develop themselves as critically reflective practitioners and advance their own learning to sustain continuing professional development
• Critically evaluate literature, theories and methodologies and apply approaches to creating a clinical trials project plan

Summary of Teaching

This unit 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 contain ten hours of assessed learning.

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

Assessment

Assignment (3000 words) 100%

Learning Outcomes

Knowledge

Demonstrate an advanced knowledge and detailed understanding of the:

• historical background of how clinical trials have developed
• and evolved to modern standards
• drug development process
• basic requirements for developing and conducting clinical trials
• practical and theoretical aspects of the design, conduct,
• analysis of outcomes and reporting of clinical trials
• ethical and regulatory aspects of the proper conduct of trials

Skills

Critically analyse, evaluate and where appropriate formulate an informed opinion about:

• Clinical trial reporting
• Impact of poor practices in clinical trial conduct
• Effectiveness of current systems and processes
• Analyse approaches to project management
• Offer guidance on Project Management in Clinical Trials, including Project Management Tools and how to use them effectively, and how to
• Plan approaches to manage when things don’t go as planned, for example when there are unexpected outcomes or accidents in the conduct of clinical trials
• 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
• Network with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation

Transferable skills

• The ability to critique information from a range of sources to formulate opinions
• Project manage in accordance with organisational requirements, demonstrating high level knowledge on a process driven approach
• The ability to assess current working practices based on knowledge and experience gained and adapt working practices as necessary
• The ability to prioritise and effectively manage time to complete work by required deadlines

PHAR69924 Literature Review and Research Protocol in Modelling and Simulation

Unit Lead: Dr Kayode Ogungbenro

This is a research unit, in which students conduct a literature review on a topic of current importance in the general area of Modelling, Simulation and Data Analysis. The primary aim is to synthesise new knowledge by gathering the discrete pieces of information, identifying the gap in knowledge and writing a detailed research proposal.

Assessment

Research proposal of approximately 5,000 words (100% of unit marks)

The report should comprise a focussed literature review concluding with a detailed modelling & simulation project proposal (research protocol).

Skills to be assessed:

• Recognise and explain the role of M&S in PK/PD and drug development
• Perform a thorough review of M&S literature in a specific therapeutic area and identify the key references
• Summarise the previous work, showing insight into the strengths and weaknesses in the key references
• Identify gaps that can be addressed by M&S
• Construct a feasible modelling project to address the gaps identified in the existing literature
• Present a convincing rationale for carrying out the work, including sufficient detail on modelling approach and data
• Produce a written document (research proposal) that communicates in a professional, precise and clear manner what you are hoping to achieve

Assessors are asked to comment on the extent to which the paper is successful in these areas:

1. Context and rationale [20% of marks]
2. Does the paper describe the clinical and drug-development background to the problem? Is the role and potential contribution of PK/PD modelling clear, so that the reader can appreciate the rationale for modelling in this situation?
3. Literature review [30%]
4. Does the summary of PK/PD background reference all the key work in the area? Does it indicate understanding of the important points, rather than just listing results without explaining significance? Does the discussion of strengths and weaknesses demonstrate insight and critical analysis of the published modelling approaches?
5. Proposal [30%]
6. Is the proposed modelling work novel? Does it address a real gap, and is that gap clearly explained? Is the work described with sufficient detail as to the modelling approach and the data required? Does the proposal present a convincing case that 1) there is a need for the work, and a significant anticipated reward for a successful outcome, and 2) the proposal contains sufficient detail to give confidence of successful outcome.
7. Presentation [20%]
8. Is the presentation clear and professional in tone, so as to give the reader confidence in the abilities of the writer? Is the referencing appropriate? Are Figures and Tables clear and relevant to the review and proposal, with informative captions that point out the key features and intended purpose of the figure/table? Is the language grammatical and free of typographic errors?

PHAR69920 Dissertation / Supervised Research Project

Unit Lead: Dr Kayode Ogungbenro

This is a research unit and follows on directly from the literature review and research protocol in modelling and simulation (PHAR69924). Students carry out the research project proposed in PHAR69924, i.e. on a topic of current interest that addresses the issues raised in their review project. The research should have elements of data analysis, modelling or simulation and is supervised by one academic supervisor. The dissertation should be written as an MSc thesis and the major results should be worthy of publication in pharmacokinetic journals.

The total time spent on the research and writing the dissertation should be based on 10 notional learning hours per credit (i.e. a total of 600 hours teaching for this 60-credit unit). The projected hours of independent study are intended as guidelines only, but are important to ensure a balanced workload between the units.

Supervisory Sessions (10T x 2H) = 20 h

Independent Study (P x 560H) = 560 h

Assessment

Dissertation (12,000 – 15,000 words) 90%

Oral Presentation (via Web Link for part-time students) 10%

(The oral presentation will normally take place before the final Dissertation submission.)

Learning Outcomes

This unit aims to give the opportunity and environment where the students take a leading edge piece of research work and employ the knowledge that is gathered through other modules of the course. The research must be an applied PKPD or M&S project and it should add to the existing knowledge in the area.

Knowledge:

• Gain scholarly knowledge in a focused area of M&S
• Knowing how to identify an appropriate research question
• Select methodology
• Appraise the relevant literature
• Gained the knowledge and understanding to be able to produce a report that is publishable in a peer reviewed journal relevant to the area

Skills:

• Gain scholarly knowledge in a focused area of M&S
• Apply the knowledge and skills gathered in other modules within a well defined research project,
• Execute and complete a piece of research which is narrowly focused on specific area of M&S,
• Develop the ability to debate the outcome of research and argue for validity of the methods used in the study and the conclusions drawn from the results.

Transferable Skills:

Develop the ability to debate the outcome of research and argue for validity of the methods used in the study and the conclusions drawn from the results.

 

Section C: Information about the Division and University

Divisional Administration Contacts 

Head of Division: Prof Kaye Williams

Head of Divisional Operations: Victoria O’Reilly

The Division address is:

Division of Pharmacy and Optometry
School of Health Sciences
Jean McFarlane Building
Oxford Road
Manchester
M13 9PL

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

School of Health Sciences Teaching, Learning and Student Experience Staff :

In order for staff to respond as quickly as possible to your request, and to ensure that your request reaches the correct member of staff, we have set-up dedicated email addresses that serve a different function.  If your query relates to any of the below, please email the relevant email address.

Email Address	Supports queries about:
shs.assessment@manchester.ac.uk	Examination queries Assessment queries Assessment submissions Resit/reassessment queries
shs.attendance@manchester.ac.uk	Attendance monitoring
shs.dc@manchester.ac.uk	Disability support
shs.mitcircs@manchester.ac.uk	Mitigating circumstances
shs.placements@manchester.ac.uk	All placement queries
shs.programmes@manchester.ac.uk	Registration advice and guidance Course unit selection and enrolment Timetable queries Programme content
shs.wellbeing@manchester.ac.uk	Wellbeing student support, appointments and signposting
shs.hub@manchester.ac.uk	Student Support Hub – general queries and advice not covered by the above teams

As these inboxes are associated with staff supporting multiple programmes, please could you ensure that you always include the following details in your email, which will help us to ensure that your message is dealt with promptly:

Full Name

Student ID Number

Year of Study

Programme

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. You should also ensure that as soon as your contact details change that you update them on the system as well as informing the Graduate Administrator for your file.

Progress Committee

The MSc Programme Board, and ultimately the Pharmacy and Vision Sciences Postgraduate Consortium 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.

Computing Facilities

Further details can be found on the following web page:

http://www.itservices.manchester.ac.ul/pcclusters/

In addition to the computers in the Division of Pharmacy and Optometry there are a number of public facilities elsewhere on campus. In particular there are large clusters of machines with printers in John Rylands University Library and Manchester Computing (Kilburn Building), and smaller clusters in the Arts Building and the Stopford Building (The Medical School). The porters in each of these buildings will direct you to the right room. The Stopford Building is open 24 hours a day.

Students can access the internet without restriction, but you will find that there are web “rush hours” when the large number of people trying to access the system from elsewhere practically brings it to a standstill. First thing in the morning is the best time for serious net surfing. Our own computers are heavily used for real work during the day so please don’t play on the internet while other students are queuing for a machine.

Working with your own computer

Some students may have their own computers. If you have such facilities then you should check that your system is compatible with the one in Pharmacy. This will help avoid problems when you try to transfer documents from your machine to ours.

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.

Login to the Support Centre online to log a request, book an appointment for an IT visit, or search the Knowledge Base.

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://elearning.bmh.manchester.ac.uk/student/technical-support/

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.

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

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://stream.manchester.ac.uk/Play.aspx?VideoId=30453
• https://youtu.be/47pA877MKJg

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

• Students should access Blackboard via MyManchester
• Queries (technical related) should be directed to: elearning@manchester.ac.uk
• Queries (course content related) should be directed to the relevant Unit Lead

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 .

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.

Training materials to help you make the most of the Library’s resources will be available via the following link:.

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

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

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/

Student Support Services

Student Support and Wellbeing Team

The Student Support and Wellbeing Team can support your wellbeing needs through the year. The team is here to support you when you wish to discuss circumstances such as interrupting your studies, financial issues, the submission of details of mitigating circumstances and any personal concerns that are affecting your ability to study and engage fully with your course. It is important to point out that Student Support is not a counselling service; it is a practical support service.

Support from the University

As a student at the University of Manchester, you have access to a huge range of support services and resources. This includes, but is not limited to, support relating to your studies, finances, health and wellbeing, settling in and making friends, personal safety and planning for your future beyond University.

Students’ Union Advice Centre

The Students’ Union has advisers who can help with any matter ranging from finances to housing and beyond. The Advice Centre is on the first floor in the Student Union Building, and is open Monday to Friday, 9.30am to 4.30pm, term time and vacation. See http://manchesterstudentsunion.com/.

Support of care experienced and estranged students

The University of Manchester recognises that care experienced students, and those that become estranged from their families often require additional support. This may take the form of, amongst other things, financial support, help with accommodation, provision of quiet study are as and general support. Please contact shs.wellbeing@manchester.ac.uk for further details on how to access support.

Support for Students with Disability and Long-Term Health Problems

If you have a disability, or have learning support needs, we advise that you register with the Disability Advisory and Support Service (DASS). They can offer a range of services to help you make the most of your University experience. Where appropriate, they will work with you to develop a support plan which will put in place any support you require for exams, from the library or from teaching staff.

Registering with DASS is particularly important for students where ongoing or recurring difficulties may impact their academic performance. The University’s Policy on Mitigating Circumstances (see section 6) does not allow students to make repeated claims for the same condition, because to qualify for mitigation, the circumstance must be ‘unforeseeable’. However, the Mitigating Circumstances Committee can award further mitigation where DASS support your claim; for example, by advising the committee that your condition is associated with ‘flare-ups’ (which are unforeseeable).

You find more information and how to register with DASS here: http://www.dass.manchester.ac.uk/

Support for International Students

Manchester has a thriving International student community and you will have lots of opportunities to engage with students from all over the world. The International Society (http://www.internationalsociety.org.uk), based on Oxford Road, organises trips, events, activities and community projects which are open to both International and British students. The Language Centre also provides support to International students who have concerns about their English skills (http://www.languagecentre.manchester.ac.uk/).

UoM Counselling Service

The Counselling & Mental Health Service works in partnership with other support services within the university and are here to provide support for you should you feel you need help with your mental health.

The Counselling & Mental Health Service offer a range of workshops, groups, 1-1 appointments and other resources to help you. For more information and to book an appointment click here: Get Help

You can also phone for advice on 0161 275 2864 between 9.00am – 4.30pm (Monday – Friday)

Student Support and Wellbeing Contact Details

shs.mitcircs@manchester.ac.uk – for information and guidance on mitigating circumstances and extensions, including sending evidence and receiving outcomes of applications.

shs.attendance@manchester.ac.uk – for queries related to attendance monitoring.

shs.wellbeing@manchester.ac.uk – for support and signposting to university wellbeing resources, as well as making a wellbeing appointment with an advisor.

shs.dc@manchester.ac.uk – for Disability Advisory and Support Service (DASS) enquiries.

Attendance monitoring and Student Ill Health

Students are expected to attend all scheduled teaching and learning sessions in every year of study, unless alternative arrangements or flexibility in attendance has been agreed for individual students, if unavoidable circumstances such as illness prevents you from attending or if absence has been authorised. This includes both on-campus teaching as well as online/blended, distance or remote learning modes of delivery.

If you are unable to attend a teaching session you should inform the lecturer/instructor in the first instance to catch up on missed learning and for support with teaching materials. For absences of 1-2 days, you do not need to tell the Student Support and Wellbeing Team.

If you expect to miss one or more full weeks of teaching, you must notify the Student Support and Wellbeing team on shs.attendance@manchester.ac.uk, as well as your Academic Advisor. Please provide a reason for this to help the team provide appropriate guidance and signposting as required.

If your attendance is deemed to be too low, someone from the Student Support and Wellbeing team will be in touch to check in with you and make sure that you are ok. If the poor attendance continues without a valid reason, your Academic Advisor will be informed. If there is still no improvement in your attendance, you will be asked to a meeting with your Programme Director. This is in line with the university policy on monitoring attendance.

Tier 4 Visa Students

As a part of your visa requirement, your attendance needs to be monitored with regular in-person check ins on campus. You will need to attend the SHS Hub (Ground Floor, Jean McFarland building) twice a week on your assigned days to scan your student ID card.

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/

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
Guidance for the presentation of Taught Masters 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: Fasting and Caring – Looking after yourself and your patients during Ramadan: guidance for health care students.

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

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
http://bmh-elearning.org/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/