Postgraduate Diploma in Medicines Development- PG Dip

(Med Dev)

Programme information

Location:

Faculty of Medicine and Health Sciences, Tygerberg, Cape Town

Programme Language:

English

Assessments:

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