Regulatory Affairs

Module Objectives

The module covers the key regulatory issues affecting the industry today from an overview of the major drug regulators and the requirements during drug development to medical information and regulations including prescribing issues to life cycle management issues.

Intended Module Learning Outcomes

After successfully completing this module students will be able to:

Evaluate the regulatory issues affecting the pharmaceutical industry.

Compare the regulation of medicines in different global markets.

Develop and critically appraise product-related information to ensure adherence to ethical and legal provisions.

Regulatory Affairs
Regulatory Affairs