Module 6

02/10/2024

MSc Module 6: Regulatory Strategy: From Development to the Market Place

Welcome and Introduction to Module 6

7th to 9th October 2024

Vina Mistry

Independent Regulatory Consultant: Pharmistry Consulting Ltd

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Module 6: Aims and Learning Outcomes

Module 6 Aims

• To consider and evaluate practical regulatory aspects of regulatory strategy for commercialising products and maintaining the brand from development stages to registration and throughout the product lifecycle; • To explore and critically debate the regulatory issues likely to arise during commercialisation of products in order to be able to provide effective advice as necessary.

Module 6 Learning Outcomes

• To recognise the needs of marketing colleagues in commercialising products and maintaining brand awareness through new drug development, new indications and switching of legal status; • To demonstrate how the marketing life of a product can be optimised by use of patents, supplementary protection certificates, data exclusivity; • To optimise the needs of pricing and reimbursement committees, such that any commercial advantages may be gained; • To understand the importance of the SmPC as a means of communication with prescribers and as the basis for advertising and patient information; • To understand the constraints of advertising and promotion of pharmaceuticals and OTC medicines; • The responsibilities and requirements for keeping licences current wrt pharmacovigilance and adverse drug reaction and risk management. • Differentiate the internal and external activities and interactions associated with a product issue or during crisis management.

The Organisation for Professionals in Regulatory Affairs

Module 6: Welcome and Introduction

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