Master of Philosophy in Medicines Development

Purpose

The purpose of this qualification is to provide learners with an essential step in the training of scientists in Pharmaceutical Medicine and will address an obvious need that has been recognised across the world. The target group will include suitably qualified learners and will also appeal to learners from African countries. A qualified learner will be able to:

• Explain the multidisciplinary nature of pharmaco economics and ethical boundaries, and the need for integration of knowledge from a range of health science disciplines in the management of sustainable health service challenges in the 21st century.
• Explain the role of Pharmaco vigilance in monitoring of drugs in non-clinical and clinical research and in the marketplace.
• Apply regulatory, ethical and legal issues that are peculiar to biological and advanced therapies.
• Relate life time changes in body composition and function to drug effects in different age groups.
• Outline pharmaco vigilance, pharmaco epidemiology, risk management plans and consider the extent of unlicensed and off-label use of medicinal products in children.
• Appraise different methodologies for carrying out systematic review and meta-analysis.

Rationale

The Master of Philosophy (MPhil) in Medicines Development is a scientific area with a growing demand in academia, the private sector, drug regulatory agencies and pharmaceutical industry. There are too few specialists, and there is an increasing interest of medical doctors, pharmacists and other scientists to specialise in this field. The MPhil in Medicines Development would therefore cater for a training need for the country as a whole and also for Africa in general.

Support is built into the qualification in order to aid the learners with their research assignments, and regular interaction with their individual supervisors for the projects. One-on-one and continuous assessment and direct contact with learners will address their needs. Specific learner needs covered will include access to resource material, research support and developing expertise in developing a research assignment, guidance in writing the project, personal development, access to needed equipment and support etc.

The qualification will address the needs of a variety of stakeholders, including the national and provincial Departments of Health (especially the Medicines Control Council, MCC), the pharmaceutical industry, clinical or laboratory-based contract research organisations, and hospital clinical trial units. Given the critical shortage of experts in medicines development nationally, the health services of the country will eventually benefit from the qualification.

Recognition of Prior Learning (RPL)

The institution has an Assessment Policy and Recognition of Prior Learning (APRL) policy in place.

The qualification conforms to the institution's Policy for the Assessment and Recognition of Prior Learning (RPL) as well as the RPL policy of the Faculty of Medicine and Health Sciences.

The policy defines the process that must be followed in the assessment of an application for Recognition of Prior Learning (RPL) at postgraduate level and provides information pertaining to assessment tools that can be used in the assessment of RPL applications. The RPL process is subjected to the Faculty's quality assurance process.

Entry Requirements

Admission requirements for the following qualification are as follows

• Postgraduate Diploma in Pharmaceutical Medicine.
• Bachelor of Medicine and Bachelor of Surgery (MBChB) or (BChD) Degree.
• Bachelor of Pharmacy (BPharm).
• Baccalaureus Curationis, Bachelor of Science in Biological Sciences or Biomathematics Degree.

This qualification comprises compulsory modules at NQF Level 9, totalling 180 Credits.

Compulsory modules at NQF Level 9 (practical work, skills and procedures)

• Module I: Health economics, 20 Credits.
• Module II: Drug safety, pharmaco epidemiology, pharmaco vigilance. Risk management, 20 Credits.
• Module III: Biologicals and advanced therapies, 20 Credits.
• Module IV: Vulnerable diseases and clinical trial practices, 20 Credits.
• Module V: Medicines Development in Children, 20 Credits.
• Module VI: Systematic review and meta-analysis, 20 Credits.
• Research assignment, 60 Credits.

1. Explain the multidisciplinary nature of pharmaco economics and ethical boundaries, and the need for integration of knowledge from a range of health science disciplines in the management of sustainable health service challenges in the 21st century.
2. Explain the role of Pharmaco vigilance in monitoring of drugs in non-clinical and clinical research and in the marketplace.
3. Apply regulatory, ethical and legal issues that are peculiar to biological and advanced therapies.
4. Relate life time changes in body composition and function to drug effects in different age groups.
5. Outline pharmaco vigilance, pharmaco epidemiology, risk management plans and consider the extent of unlicensed and off-label use of medicinal products in children.
6. Appraise different methodologies for carrying out systematic review and meta-analysis.

Associated assessment criteria for Exit Level Outcome 1

• An appropriate manner of fundamental scientific theories underlying the application of health economic techniques to a range of healthcare interventions is applied.
• Basic relationships and techniques of healthcare management are recognised and utilised to maximise benefits from a given resource.
• Information associated with economic appraisal and assessment of new medicines carried out by NICE or similar agencies is explained and presented.
• The role of the agencies which police the economic viability of existing and new medical technologies is explained.
• The different challenges of healthcare expenditure in different economies are presented.
• The structure of the global drug development and regulatory framework with emphasis on risk management in the context of benefit/risk assessment and the role of pharmaco economics and quality-of-life is outlined.
• The methods utilised in clinical trials for examining cost-effectiveness of new pharmaceutical products are explained.

Associated assessment criteria for Exit Level Outcome 2

• Common nomenclature associated with pharmaco vigilance (inc. AE and ADR, Listedness, and Expectedness etc) is appraised.
• The sources of safety data: methods for collection, analysis, interpretation and reporting drug safety data, including electronic safety data reporting are demonstrated.
• The assessment of causality is evaluated.
• The application of signal generation and handling of drug safety data in pre-marketing (clinical trial) and post-marketing (pharmaco vigilance) contexts is analysed, including automated methods.
• The principles of pharmaco epidemiology and the examination of the different types of pharmaco epidemiological studies used are explained in evaluating drug safety including the choice of the most appropriate study design.
• Pharmaco vigilance aspects of medicines regulation throughout the life-cycle of a medicine are described.
• The principles of risk-benefit analysis and management using qualitative and quantitative approaches are critically appraised.
• The background and purposes of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) are evaluated.
• The role of the EU Qualified Person in Pharmaco Vigilance (QPPV) is described.
• Major routes for reporting and communication of pharmaco vigilance data are described.
• The aetiology, mechanisms and pathology of major classes of adverse drug reactions and interactions is evaluated.

Associated assessment criteria for Exit Level Outcome 3

• Challenges presented in constructing a package of non-clinical data are resolved to support the clinical development and marketing of biological and advanced therapies.
• A clinical trial plan that is appropriate for the different types of products and technologies represented by biological and advanced therapies is recommended.
• Technical and manufacturing issues that are peculiar to biological and advanced therapies are addressed.
• General articles on new or prospective biological or advanced therapies, published papers describing the clinical trials of biological and advanced therapies are reviewed.
• The new technologies that are available and those in development and the therapeutic opportunities that might arise from the technology are described.
• The differences between natural and modified proteins are critically analysed.
• The global need for new and improved vaccines and the barriers to their development is described.
• A therapeutic vaccine and how it could influence therapy in a common disease area is described.
• The history and future prospects for gene therapy, and the technical difficulties developing a gene therapy product are discussed.
• The concept of stem cell therapy, what opportunities it might present, and the ethical issues that are unique to this technology are described.
• The particular ethical and regulatory issues of advanced therapies are described.

Associated assessment criteria for Exit Level Outcome 4

• Clinical drug development programmes tailored to medical needs, age specific physiological differences, and ethical issues, legal and regulatory requirements are created.
• Non-clinical and clinical drug development programme is planned considering the specific conditions of pregnant and lactating women and of the breast-fed baby.
• Pharmacokinetic behaviour and pharmaco dynamic effects of drugs in the elderly with those observed in the normal adult population are compared.
• The need to develop drugs with elderly specific strength, combinations and drug containers making drug application easier in old patients is considered.
• The therapeutic needs of elderly patients are assessed and balanced with the specific legal and ethical issues related to trials involving this specific population.
• The scientific, socio-ethical, pricing and reimbursement problems related to developing and marketing orphan drugs is evaluated.
• A clinical drug trial protocol considering scientific goal(s), target patient population, suitable methods and feasibility is designed.
• A clinical project plan with budget and risk management strategies is prepared for execution and evaluation of clinical trials under complex circumstances.>� Life time changes in body composition and function to drug effects in different age groups are discussed.

Associated assessment criteria for Exit Level Outcome 5

• The ethical, legal, methodological and technical aspects of the involvement of children in clinical research are critically reviewed.
• The potential, long-term, adverse effects that children are exposed to during different phases of growth and maturation are described.
• Various pharmaco dynamic and pharmacokinetic models used in developing medicines for children are analysed.
• The principles of conducting meta-analyses and systematic reviews on medicinal products for children are explained.
• Contrast specific issues related to developing medicines in children of different age groups are compared.
• Vaccine development process in children is evaluated.
• The burden of disease in the different age groups in comparison with adults is evaluated.
• Galenic formulations of medicines developed for children are described.
• The differences in pharmacological treatments between male and female adolescents are discussed.

Associated assessment criteria for Exit Level Outcome 6

• Statistical approaches used in meta-analyses are outlined.
• Meta-analysis for post-hoc evaluation of clinical trial data is applied.
• Treatment effects by subgroups using individual patient data are evaluated.
• The role of meta-analysis and systematic review in evaluating adverse events are identified.
• Current strategies using meta-analyses in the Marketing Authorisation process are explored.
• The role of meta-analysis and systematic review in generating evidence-based treatment guidelines is explained.
• The role of meta-analysis and systematic review in pharmaco-economic evaluation is described.
• The process of writing and publishing a meta-analysis and systematic review is outlined.

Integrated Assessment

All internal and external assessment and moderation will take place in accordance with the policy document of the University (Regulation for internal and external moderation and the processing of results).

Both formative and summative assessments will be used to assess the learners applied competencies in the qualification.