Universities and Online Degrees Guide

Stellenbosch University

Postgraduate Diploma in Medicines Development

The Postgraduate Diploma in Medicines Development in Health Professions is offered by Stellenbosch University.

Program Length: 2 YEARS.

Subjects: 6.

Postgraduate Diploma in Medicines Development offered by Stellenbosch University at the Faculty of Medicine and Health Sciences

Programme description
The Postgraduate Diploma in Medicines Development (PG Dip (Medicines Development)) aims to provide you as appropriately qualified scientist with a programme of study that would expand your knowledge and skills in medicines development/pharmaceutical medicine. Medicines development/pharmaceutical medicine deals with the entire medical product life cycle, including non-clinical and clinical drug development, regulatory affairs, marketing of pharmaceutical products and drug safety/pharmacovigilance. Specifically, this discipline encompasses the following areas:

• Discovery of new medicines;
• Pharmaceutical development;
• Toxicity testing;
• Legal and ethical issues;
• Development of medicines and development planning;
• Clinical trials;
• Statistics and data management;
• Safety of medicines;
• Regulatory affairs;
• Information, promotion and education; and
• Economics of health care.

Please note: You must read the calendar entry for this programme in conjunction with the more comprehensive outline of the programme regulations provided to you upon admission to the programme.

Programme outcomes
The programme also aims to enhance the quality of scientists working on the development and testing of new drugs, and to provide for professional development in the discipline of medicines development/pharmaceutical medicine. As a graduate of the Postgraduate Diploma in Medicines Development programme, you must:

• have a thorough and systematic knowledge of pharmaceutical medicine and medicines development;
• be able to critically evaluate and practically apply new knowledge, understanding and skills to the discipline of medicines development/pharmaceutical medicine in South Africa; and
• be able to evaluate and reflect on your personal and professional strengths and weaknesses in order to change your professional practice in an appropriate manner according to the best evidence available.

Programme content

First year

Introduction to Pharmaceutical Medicine, Drug Discovery and Development Planning (30)
Non-clinical and Pharmaceutical Development of Medicines (15)
Clinical Development of Medicines (15)

 

Second year

Biometrics, Epidemiology and Data Management (15)
Health Care Marketplace and Economics of Health Care (15)
Regulatory Affairs, Ethics, Drug Safety and Pharmacovigilance (30)

 

Assessment and examination

• To be awarded the Postgraduate Diploma in Medicines Development, you must:

• complete two calendar years as a registered student for the PG Dip (Medicines Development);
• obtain at least 50% in your modular tests during the two-year programme; and
• pass two three-hour examination papers covering the modules.

• You must pass each of the six modules with an average mark of at least 50%.
• To complete the PG Dip (Medicines Development) programme successfully, you must obtain a final mark of 50% or more for the programme. To pass the PG Dip (Medicines Development) programme with distinction, you must obtain a final mark of 75% or more for the programme.
• The final mark for the programme is calculated as the a weighted average of the marks for each component, namely:

• two three-hour written papers (2 x 30%);
• the average mark for the six modules (15%); and
• an oral examination in the presence of an external examiner (25%).