MSc MODEL-BASED DRUG DEVELOPMENT
PROGRAMME HANDBOOK
2022/23
https://handbooks.bmh.manchester.ac.uk/2022-23/shs/pg/msc-model-based-…handbook-2022-23
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.
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 |
| 27 September 2021, 6 weeks |
Unit: Basic PK/PD (PHAR69921) | Unit: Introduction to clinical trials (PHAR72010) |
| 1 – 5 November, | Due: Report & Oral presentation | Due: Clinical Trials Coursework |
| 8 November,
6 weeks |
Unit: Biostatistical concepts (PHAR69931) | Unit: Physiologically-based PK &IVIVE, part 1 (basic concepts) (PHAR69922) |
| January | Exams: Basic PKPD | Due: PBPK1 report & presentation
Exams: PBPK1 |
| February 2023, 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 and oral presentation |
| 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 2023 | FT only: Graduation | |
| January 2024 | PT only: Due: Dissertation and oral presentation | |
| July 2024 | PT only: Graduation |
Programme Staff
The core teaching staff on the course are listed below:
Leon Aarons, BSc, MSc, PhD
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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
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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
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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
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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
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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 submissions
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:
Policy on the Submission of Work for Summative Assessment on Taught Programmes
Extensions
Students can only make requests for extensions and mitigating circumstances if the requests are accompanied by appropriate supporting documentation and using the correct form.
Requests must also be made more than 1 working day (by 12pm, midday) prior to the submission deadline
How do I apply?
Please note that only 1 extension per assessment per attempt is available. If you are granted an extension and still unable to submit by the extension deadline, you need to submit a Mitigating Circumstances Form (see information above).
Students should complete and submit an Extension Request Form no later than 1 working day (by 12pm, midday) prior to the submission deadline. You should state the amount of extra time you require to complete your work by adding the date you feel you can complete by, the Student Support and Wellbeing team along with the Examinations Officer will agree on an acceptable deadline taking into account the marking timeframes of the course unit. The link to the form can also be found on the front page of any online submission area on the course units on blackboard. If you are unable to meet the agreed extension deadline, no further extension can be granted, however you can complete a mitigating circumstances application if there have been circumstances affecting you following your request for an extension.
You must submit evidence to support your application and send to this to shs.mitcircs@manchester.ac.uk. You can see examples of appropriate evidence above under
‘What evidence do I need?’
Please note extensions cannot be granted on exams.
Provisional extensions can be granted in exceptional circumstances where evidence cannot be sought initially. However, if the requested evidence is not submitted before the provisional extension submission date, the extension will become null and void.
Once an extension is confirmed the student will be notified by email to their student email address. It is therefore important that students regularly check their account for important programme and assessment-related information.
Please note that as extensions fall outside the original marking period this may result in a longer marking period.
Automatic 1 week extension for DASS registered Students:
As part of your support plan you may be eligible for an automatic extension of 7 days for assessed written work. The Assessment and Progression team will already have been advised of this, and it will not be necessary for you to submit an application for mitigating circumstances if you are able to submit your work within the original deadline. If the circumstances directly relating to your disability mean that you will need additional time beyond the automatic extension of 1 week, you must submit an Extension Request Form. Please note that automatic extensions do not apply to group-work, presentations or other forms of assessment, and you must submit a mitigating circumstances application if you are unable to meet the deadline for anything other than assessed coursework.
If you have any questions, please contact the Student Support and Well-being team, you can drop in to see them in the SHS Student Hub, ground floor of the Jean McFarlane Building, or email them at shs.wellbing@manchester.ac.uk, or telephone: 0161 306 7812.
Mitigating Circumstances
Please read this advice in conjunction with the University’s Mitigating Circumstances Policy: http://documents.manchester.ac.uk/display.aspx?DocID=4271
Mitigating circumstances are personal or medical circumstances which are unforeseeable and unpreventable that could have a significant adverse effect on your academic performance. You should only submit a Mitigating Circumstances application if you consider it serious enough, and the timing critical, to have affected your performance in your assessed work and/or examinations.
How do I apply?
The link for the Mitigating Circumstances Form can be found here Mitigating Circumstances Form, and on the front page of any online submission area on the course units on blackboard.
You must submit evidence to support your application (further information below). Please send this to shs.mitcircs@manchester.ac.uk.
If you do not have access to supporting evidence at the time of completing the form, please note this on your summary of circumstances and complete the form within the required deadline and evidence can be emailed when available.
What types of circumstances are normally accepted or not accepted?
Possible mitigating circumstances include:
- significant illness or injury; or worsening of an ongoing illness or disability, including mental health conditions; (please see the following DASS webpage for examples of disabilities: http://www.dso.manchester.ac.uk/who-do-we-support/current-students/)
- the death or critical/significant illness of a close family member/dependant;
- significant family or personal crises or major financial problems leading to acute stress; and
- absence from the University for public service, for example, jury service.
These lists are examples; other circumstances can also be considered
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;
- failure, loss or theft of a computer or printer that prevents submission of work on time; students should back up work regularly and not leave completion so late that they cannot find another computer or printer;
- the act of religious observance;
- consequences of paid employment (except in some special cases for part-time students);
- exam stress or panic attacks not diagnosed as illness or supported by medical evidence; and
- disruption in an examination room during the course of an assessment which has not been brought to the attention of, or recorded by, the invigilators (including instances such as fire alarms or other noise disruption)
Pregnancy: events may arise during pregnancy that may constitute mitigating circumstances, and these need to be judged on a case-by-case basis. It is recommended by the Equality Challenge Unit (ECU), that, at a minimum, students are required to take two weeks’ compulsory maternity-related absence, or four weeks if they are on placement in a factory. This is in line with employment law, and is to ensure the health and safety of the mother following birth.
If a student has already applied for and received an extension, to be considered for mitigating circumstances, they would need to provide additional evidence stating that the circumstances were ongoing throughout the extension period.
Students who are registered with the Disability Advisory and Support Service (DASS)
If you need to apply for mitigating circumstances due to issues directly related to your disability, you do not need to provide any additional supporting evidence, but you must provide a detailed explanation on the application form of how your disability is specifically affecting your studies at the time. It is not sufficient to indicate only that you are registered with the DASS. Additionally, if you feel that your disability has been exacerbated by an event (such as bereavement or a change of medication) then you must still provide evidence of the event itself. A Disability Advisor from the DASS will be part of the Mitigating Circumstances Committee that will consider your application. When considering your application the Committee may check on your engagement with any support you have been offered by the DASS. If support is available but you have chosen not to engage, this may be taken into consideration and reflected in the Committee’s recommendation. If you are registered with DASS but need to apply for mitigating circumstances for an issue that is not directly related to your disability, you must provide supporting evidence (see below for details).
What evidence do I need?
You should provide as much supporting information as possible with your mitigating circumstances request. This helps us to understand the severity of the situation and assess the best solution. All evidence will be treated confidentially.
You may include any evidence that supports your request, such as:
- Extracts from your medical notes (you can request these from your GP practice)
- Copy of prescription or photo of name label on prescribed medication
- Appointment cards from medical unit or hospital admissions letter
- Confirmation text of medical appointment
- Communications from a school or care facility confirming that they are closed or the person you care for is unable to attend
- An obituary or letter from a family member, in the case of bereavement
- Police, security or insurance report
- Press or media report
- Internal confirmation of existing engagement with our counselling / Advice and Response service
Mitigating Circumstances Committee
Mitigating circumstances committees take place prior to an exam board to consider submitted applications. The purpose of the committee is to establish the severity of the mitigating circumstances and to determine if they might have a negligible or significant effect on the outcomes of the assessment.
How will my application be considered?
The Mitigating Circumstances Committee will assess whether to accept or reject your application based on the information and supporting evidence you have provided.
Following the meeting the student will be informed of the outcome in writing via email. This will also be accompanied by a ‘Mitigating Circumstances Information Sheet’ with what happens next guidance.
If my application is accepted how will mitigation be applied?
Late submission of coursework (excluding PGT dissertations):
When coursework is submitted after the deadline, the student should complete the online mitigating circumstances form explaining the reasons for the late submission, together with appropriate third-party supporting documentary evidence (e.g. medical or other). Any coursework submitted after the submission deadline will be subject to the penalties outlined in the late submission policy (available in the Assessed Coursework Guidelines) unless the mitigation is accepted. If students have valid mitigating circumstances to explain the late submission and the Mitigating Circumstances Committee accept that the circumstances warranted the length of time taken to submit the work, then it will be the recommendation of the Mitigating Circumstances Committee that the penalty is waived and full marks are reinstated.
Students are advised to aim to submit outstanding coursework at the earliest opportunity and in any case within ten working days of the deadline. If work is submitted after that date it will receive a mark of 0 regardless of mitigation. If an application for mitigating circumstances is not accepted by the Mitigating Circumstances Committee (i.e. rejected), then late penalties will be imposed.
Late submission PGT dissertations:
Students are advised to aim to submit outstanding PGT dissertation at the earliest opportunity and in any case no later than twenty working days after the deadline. Students should liaise with the shs.assessment@manchester.ac.uk regarding difficulties in meeting these deadlines. When dissertations are submitted after the deadline, the student should complete the online Mitigating Circumstances Form explaining the reasons for the late submission, together with appropriate third-party supporting documentary evidence (e.g. medical or other). Any dissertation submitted after the submission deadline will be subject to the penalties outlined in the late submission policy (unless the mitigation is accepted).
If students have valid mitigating circumstances to explain the late submission and the Mitigating Circumstances Committee accept that the circumstances warranted the length of time taken to submit the work, then it will be the recommendation of the Mitigating Circumstances Committee that the penalty is waived and full marks are reinstated
If an application for mitigating circumstances is not accepted by the Mitigating Circumstances Committee (i.e. rejected), then late penalties will be imposed.
Mitigation will not result in the changing of any marks.
Instead, the Board of Examiners will note how much of the unit was affected. Normally students will be offered a first sit opportunity. In very serious cases, the Board may also agree to apply general mitigation to your overall performance for an academic year or offer an opportunity to repeat the year.
Missed examinations or non-submission of coursework:
In the case of a missed examination, this will normally be re-scheduled for the August examination period.
In the case of a non-submission of coursework, you will be issued with a new submission date which will be set by the Board of Examiners.
How will I find out the result of my application?
You will be notified of the outcome of your application by email to your student email address. All marks are provisional until the Final Examinations Board. The Committee will recommend to the Board of Examiners whether mitigation should be applied.
Students do not have the right to appeal against the recommendation of a Mitigating Circumstances Committee, although they can appeal against the final decision of an Examination Board, or equivalent body, under regulation XIX (Academic Appeals Procedure) once the results have been published.
What support might I be offered after submitting a mitigating circumstances form?
The Student Support and Wellbeing (SSW) team can help you to access the relevant support services within the University. If you have disclosed personal/medical circumstances on your application the SSW team may contact you and ask for your permission to complete a referral to the relevant University support service.
You will notice on the form that you are asked to declare that you understand and consent to the University sharing any relevant personal data about you between departments (e.g. School, Mitigating Circumstances Panel, DASS), based on the information disclosed on the form.
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.
The School 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.
The Faculty eLearning team have produced a short introduction to Blackboard for new students. The recording is hosted in two places: the VLS and on YouTube:
- https://video.manchester.ac.uk/faculties/52f9b4cd447aa2fbeb47d1926186f80b/46971601-1356-43e2-8e78-e9f8997821f0/
- https://youtu.be/47pA877MKJg
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.
Attendance
Attendance at taught classes and supervision tutorials is compulsory and registers are taken. If your attendance or participation is unsatisfactory then you will be reported to the MSc Programme Committee and, ultimately, to the Pharmacy and Vision Sciences Postgraduate Consortium Committee. Of course we realise that students will sometimes be unable to study for very good reasons due to personal or family circumstances, or illness; if this happens to you we will only know if you tell us, and we ask that you account for any period of absence which involves missing any scheduled session. In case of illness you should supply a doctor’s certificate or, if the illness is brief, a self-certification form can be obtained. If you are absent for other reasons then you should contact the Programme Director, explaining the circumstances. Medical certificates or letters should be submitted to the shs.attendance@manchester.ac.uk. Whatever your reason for being away, please inform your supervisor or academic advisor about it and make any necessary arrangements to catch up with work you have missed. If you have failed to hand in a piece of assessed work as a result of your absence, be sure you have complied with the rules outlined above for late submission.
The Programme Committee monitors all cases of absence, and students who do not participate satisfactorily will be asked to meet the Committee and give good reason for their lack of engagement.
The University Policy on Monitoring Attendance and Wellbeing of Students can be found at Regulation XX: Monitoring Attendance and Wellbeing of 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.
Requests for interruption
Students normally study for their qualification without breaking their studies. However the University recognises that it is sometimes necessary, in unfortunate circumstances, for people to interrupt their attendance. The regulations refer to this as “interruption”. An interruption allows students the chance to recover from such things as ill health; it is NOT a device to allow students to take time off because they fancy a break.
If approved, interruption would normally be granted for a period of 12 months. Thus a student would leave the University on a certain date and resume their studies on the anniversary of that date. Shorter periods of interruption are possible, but since they inevitably involve repeating some of the programme it is unusual for the University to allow them.
If you wish to interrupt you should first discuss it informally with the Programme Directors. If you decide to continue with your application, you must complete the online interruption form and send your supporting evidence to the Wellbeing Team at shs.wellbeing@manchester.ac.uk, stating your name, University ID number and programme. You can also contact the Programmes Support Team if you need further advice on the process.
Withdrawal from studies
If for any reason you want to withdraw from your studies, please contact the Wellbeing Team at shs.wellbeing@manchester.ac.uk, for further guidance. We will ask you to give notification of your withdrawal in writing, and you may be invited to speak to a member of academic staff before your withdrawal is processed. Please note that you may be liable for part or whole of the tuition fees due and/or an administrative charge if you decide to withdraw once teaching has started.
Academic Appeals
Students have a right of appeal against a final decision of an Examination Board, or a progress committee, or a graduate committee or equivalent body which affects their academic status or progress in the University.
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, Room 3.21, Simon Building, University of Manchester, M13 9PL (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/
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, Room 3.21, Simon Building, University of Manchester, M13 9PL (e-mail: FBMHappealsandcomplaints@manchester.ac.uk).
Conduct and Discipline of Students
General University information on the Conduct and Discipline of Students can be found at 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)
The University Library has produced online resources to help students in avoiding plagiarism and academic malpractice at:
Sharing Information
The University may share appropriate information relating to your health and/or conduct with external organisations such as your professional employer (for example, relevant NHS Trust Professional and Statutory Regulatory Bodies (PSRB), placement and training providers and/or regulator (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
Your representation plays a vital and important part in helping us to maintain and improve the quality of the programme we deliver. Early in Semester 1, students will be asked to select one individual to represent their interests to the MSc Programme Board. The student representative will be required to attend some compulsory training and attend one staff/student liaison committee per semester alongside all MSc board meetings throughout the year. The reps will also organise group feedback sessions at the end of each semester for all students to voice opinions on the programme. The existence of a student representative does not prevent any student from addressing suggestions or problems individually with the Programme Director or Adviser, as described above.
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: Prof Joseph Standing
Name of Institution: UCL Great Ormond Street Institute of Child Health
Position at current Institution: Professor of 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
- To develop and update the unit specification in consultation with lecturers and programme directors, ensuring a coherent selection of teaching material and assessments to fit with the overall aim of the programme and its specifications
- To liaise with programme administrators and the lecturers on their unit to ensure that the information on their unit in the programme handbook is accurate
- To liaise with programme administrators and lecturers to organise examining, marking and student feedback
- To develop and monitor the Blackboard E-Learning site for their unit, in liaison with lecturers for the sessions in their unit
- To liaise with students concerning queries relating to teaching and assessments for the unit that are not specific to an individual teaching session
- To attend programme meetings and the programme exam board in order to liaise with programme directors and student representatives
- To consider and act upon student feedback, staff feedback, and external examiner feedback, in order to modify the structure, content and processes within their unit, in discussion with the programme team
Roles and Responsibilities of Supervisors
- giving guidance about the nature of research and the standard expected, the planning of the research programme, literature and sources, attendance at taught classes where appropriate and about requisite techniques (including arranging for instruction where necessary);
- maintaining contact through regular meetings (the frequency of meetings being appropriate to the research being undertaken and agreed in advance);
- being accessible to the student at other appropriate times for advice and responding to difficulties raised by the student;
- giving detailed advice on the necessary completion dates of successive stages of the work so that the thesis may be submitted within the agreed timescale;
- requesting written work or reports as appropriate and returning written material with constructive criticism and in reasonable time;
- ensuring that for degrees where an oral examination is required the student is adequately prepared by arranging for the student to present his or her work to staff and graduate seminars.
- ensuring that the student is made aware when progress is not satisfactory and facilitating improvement with advice and guidance;
- establishing at an early stage the Supervisor’s responsibilities in relation to the student’s written work, including the nature of the guidance and comments to be offered as the work proceeds and on the draft of the thesis before it is submitted. It must be made clear to the student that research for a higher degree is undertaken within the general principle that a thesis must be the student’s own work;
- 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;
- making students aware of other researchers and research work in the department and Graduate School;
- encouraging the student to publish the research;
- providing pastoral support and advising students, where appropriate, of University support services;
- bringing to the attention of the students the health and safety regulations and academic rules, regulations and codes of practice of the University.
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
- pursuing the programme with a positive commitment, taking full advantage of the resources and facilities offered by the academic environment and, in particular, contact with the Supervisor, other staff and research students;
- discussing with the Supervisor the type of guidance and comment believed to be most helpful, and agreeing a schedule of meetings;
- ensuring that he/she is aware of the health and safety regulations and academic rules and regulations and codes of practice of the University;
- successfully completing any training programme arranged within the prescribed time period;
- taking the initiative in raising problems or difficulties, however elementary they may seem, bearing in mind that prompt discussion and resolution of problems can prevent difficulties and disagreements at a later stage;
- maintaining the progress of the work in accordance with the stages agreed with the Supervisor, including in particular the presentation of written material as required, in sufficient time to allow for comments and discussion before proceeding to the next stage. Where possible, students will be given details of the work programme for the academic year at the beginning of the year;
- agreeing with the Supervisor the amount of time to be devoted to the research and the timing and duration of holiday periods;
- checking the completeness and accuracy of the text of the thesis submitted; failure to check the thesis carefully may result in the thesis being failed or cause a delay in the award of a degree.
Section B: Syllabus, Course Units and Route through the Programme
Syllabus
| 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)
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)
Assignment– Case study report and oral presentation 60%
Formal Examination (January exam period) 40%
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:
Topics outline Interspecies extrapolation and first-in-human (FIH) design
Metabolite kinetics
mDDIs – PBPK M&S to inform drug labelling and clinical care
Complex drug interactions
Special populations –
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 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
W = Week; D = Day; L= Lecture; T= Tutorial; P = Problem Solving Assignment; H = Hour
Examination (end of year 1) 40%
Coursework (4 equally weighted assignments) 60%
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 and SPSS.
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 protocol.
Assessment
Research protocol 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 protocol) 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:
- Context and rationale [20% of marks]
- 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?
- Literature review [30%]
- 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?
- Proposal [30%]
- 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.
- Presentation [20%]
- 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 industrial mentor and another academic tutor. 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.
Information for 2021/22 academic year
Due to current covid pandemic, it has become imperative to adjust on-campus learning activities for the full-time students, activities will proceed as planned for part-time students online. For full-time students, learning activities will be conducted by a mixture of face-to-face classes on campus and live online sessions in semester one (at least). Lectures will be conducted live online as the times on the timetable through one of the University approved platforms. Workshops/tutorials and seminars will take place on campus. . Academic adviser tutorials will also take place on campus.
Lectures/workshops/tutorials and seminars will be timetabled and delivered live online or on campus. We expect only a very few lectures to be pre-recorded. While we expect online delivery to be challenging, we do not expect these changes to adversely affect your learning experience on the course. We aim to provided necessary support throughout the year to students to ensure adequate engagement with programme. This arrangements can change at any time and we will follow University guidance and government policy at all times.
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Section C: Information about the Division and University
Divisional Administration Contacts
Head of Division: Prof Jayne Lawrence
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).
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 can be found at: https://elearning.bmh.manchester.ac.uk/student/technical-support/
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. The email address is: elearning@manchester.ac.uk
Blackboard
Blackboard (an on-line learning and information environment) is available to students.
- 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
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
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:.
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
There are several options for support. The Student Hub is likely to be able to direct you to the most suitable support. Contact: shs.hub@manchester.ac.uk.
You can talk through issues such as interrupting your studies and progression, financial issues, the submission of details of mitigating circumstances, work and attendance problems and any personal concerns that are affecting your ability to study and engage fully with your course. It is important to point out that this is not a counselling service; it is a practical problem-solving service (a confidential Counselling Service is available for all students – see the following sections for further details).
Further details about student support are available on the following website:
http://www.staffnet.manchester.ac.uk/supporting-students/
Disability Advisory and Support Service
The University of Manchester welcomes students with a disability or specific learning difficulties. The University has a Disability Advisory and Support Service, who can supply further information, and staff will be pleased to meet you, by prior arrangement, to discuss your needs. Staff will liaise with your School to make the necessary arrangements for your support during your time in Manchester. The office can also provide a copy of the University’s Disability Statement, ‘Opportunities for Students with Additional Support Needs at the University of Manchester’ which sets out the policy and provision for students with a disability.
The Disability Advisory & Support Office is located on University Place, 2nd Floor, Block 2.
Contact details:
E-mail: dass@manchester.ac.uk
Phone 0161 275 7512/8518
Text 07899 658 790
Minicom 0161 275 2794
Fax: 0161 275 7018
Website: http://www.dass.manchester.ac.uk/
In addition, support is available within the School of Health Sciences: shs.dc@manchester.ac.uk
Student Guidance Service
The Student Guidance Service is a student-centred service open to all Undergraduates and Postgraduates, from all departments across the whole University. The service provides confidential advice on any academic matter, from information regarding course transfers, for example, to referrals for study skills courses, or guidance in Appeals procedures or advice on complex issues where a student’s work is being affected in any way.
http://www.manchester.ac.uk/study/experience/student-life/university/student-support/
Counselling Service
The counselling service is available for all students. It is free and consists of a team of professional counsellors. The service provides confidential counselling for anyone who wants help with personal problems affecting their work or well-being.
The service is open 9.00am to 5.00pm Monday to Friday all year round except public holidays.
http://www.studentnet.manchester.ac.uk/counselling/
Occupational Health
Occupational Health is a specialised area of medicine concerned with the way in which an individual’s health can affect his or her ability to do a job and to study and conversely how the work environment can affect an individual’s health. Their aim is to promote the physical, mental and social well-being of students and to reduce the incidence of ill-health arising from exposure to work place hazards.
http://www.occhealth.manchester.ac.uk/
Students Union Advice Service
The Students Union has advisers who can help with any matter ranging from finances to housing and beyond. To contact the UMSU Advice Service please email advice.umsu@manchester.ac.uk
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/