Regulatory Affairs covers the key regulatory and medical affairs 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.
After successfully completing this course, students will be able to:
- Evaluate the regulatory issues affecting the pharmaceutical industry
- Compare the regulation of medicines in different global markets, specifically in the EU and MENSA area
- Develop and critically appraise product-related information to ensure adherence to ethical and legal provisions.
- Compare and evaluate the different roles of Regulatory and/or Medical Affairs departments to propose consistent strategies involving the marketing of pharmaceuticals, medical information, the role of a pharmaceutical company's country medical department and licensing agreements.