Module 6

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Module 6: Regulatory Strategy from Development to the Marketplace	1
Module Programme	2
Welcome and Introduction to Module 6	5
Developing the Brand and Shaping its Market Place	7
Protecting the Brand: Intellectual Property and Data Exclusivity	45
Demonstrating Value and Market Access	71
Pharmacovigilance and Risk Management	90
An Agency Perspective: The success and failure of a medicinal product in the EU	112
Advertising and Controls on Prescription Only Medicines (POMs)	140
Issue Management	168
Communicating with Patients and Prescribers	190
OTC Switching	217
Case Study 1: Advertising and Controls on Promotional Materials for POMs	278
Case Study 2: OTC Switching	284

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