Summary of Syllabuses

Summary of Syllabuses for Each Module

The Postgraduate course is designed for Regulatory Affairs Professionals working in the pharmaceutical industry. To operate successfully, Regulatory Affairs Professionals require a thorough understanding of Regulatory Affairs in all its aspects and the ability to apply the knowledge in a strategic way.

The programme of individual modules was developed to provide the wide knowledge base necessary to fulfil the Regulatory Affairs function. The syllabus encompasses major aspects of pharmaceutical legislation, scientific principles and commercial practice underpinning the role of Regulatory Affairs.

Module 1 represents a platform for understanding pharmaceutical legislation and industry issues necessary for optimising the contribution of the regulatory function to development of strategic product management in both large and small companies. Modules 2, 3 and 4 concentrate on critical evaluation of scientific issues and implications for drug development in the three areas of data required for product registration, ie. chemistry and pharmacy, preclinical and clinical. Appreciation of the regulatory, legal and practical obligations in conducting clinical research and successful marketing are considered in Modules 5 and 6 respectively. Critical issues for registration of new dosage forms containing established active substances and other abridged registration applications are assessed from a procedural perspective in Module 7 and from the perspective of data requirements in Module 8.

In addition to the basic programme provided by Modules 1 to 8, modules on more specialised topics are included. Currently these cover the following topics:

• specific product types of major regulatory importance such as biological and biotechnological products and medical devices (Modules 9 and 12)
• special features of operating in the major pharmaceutical market of the USA (Module 11)
• optimising the management function of Regulatory Affairs to fulfil its crucial role in contributing to drug development throughout the product lifecycle (Module 10)