Clinical Pharmacology
Welcome to Stellenbosch University

Division of Clinical Pharmacology

Postgraduate Diploma in Medicines Development- PG Dip

(Med Dev)

Programme information


Faculty of Medicine and Health Sciences, Tygerberg, Cape Town

Programme Language:



Students must present assignments for each of the contact sessions. A written examination is held after each contact session. All modules must be passed with a minimum of 50% (combined mark for examination and assignments) to be eligible to sit for the final examination which consists of 2 written papers and an oral examination in the presence of an external examiner.

Outline of Taught Modules:

Module I: Introduction to Pharmaceutical Medicine, Drug Discovery and Development of Medicine

  • Approaches to drug discovery
  • Genomics, proteomics
  • Laboratory and animal testing of new compounds for biological activity
  • Significance of preclinical animal data for application in humans
  • Laws and patent protection
  • Pharmcodynamics
  • Pharmacokinetics


MODULE II: Non-Clinical Development of Medicines

  • Formulation development
  • Principles of testing formulations for bioequivalence, impurities, stability
  • Preparing of placebo and clinical trial materials
  • Drug delivery systems
  • Good Manufacturing Practice (GMP)
  • Toxicology of pharmaceuticals
  • Comparison between the toxicology of compounds in animal models and man
  • In vitro and in vivo tests to assess toxicity
  • Mechanisms of tissue damage; genotoxicity


MODULE III: Clinical Development of Medicines


  • Strategic planning, development and organization of a clinical trial from conception to finalization
  • First administration of new substances to humans


MODULE IV: Biometrics, Epidemiology & Data Management


  • Statistical principles in drug development and regulation
  • Principles of clinical epidemiology


MODULE V: Regulatory Affairs, Ethics, Drug Safety and Pharmacovigilance


  • Principles of drug an device regulation
  • The ethical review process, Good Clinical Practice (GCP)
  • Legal issues
  • Classification of mechanisms of adverse events
  • Methods of assessing and monitoring adverse events


MODULE VI: Health Care Marketplace and Economics of Health Care


  • Principles and practice of marketing and competition
  • Scientific writing and critical evaluation of publications
  • Principles of health economics and of pharmacoeconomics
  • Costs of clinical trial management
  • Pharmaceutical Medicine in developing countries