Module 6 - Regulatory Strategy: From Development to the Market Place - 7FHH1144

Regulatory Strategy: From Development to the Market Place

Next course: September/October 2022

Enables students to consider and evaluate practical regulatory aspects of regulatory strategy for commercialising products and maintaining the brand from development to registration, and throughout the product lifecycle. It covers the regulatory issues likely to arise before and during commercialisation of products in order to be able to provide effective advice as necessary.

Overview

This module enables regulatory professionals to increase their understanding of all aspects of the regulatory strategic issues related to defining and shaping the brand, protection and maintenance of brand awareness throughout the product lifecycle. It allows them to examine the regulatory requirements imposed on commercial medicinal products.

Subjects very well explained with relevant examples.”

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Have a conceptual understanding that enables them to evaluate critically the different strategic approaches to product lifecycle management and drug development
• Possess a critical knowledge of the regulatory requirements, directives and international requirements for commercialising products and maintaining the brand
• Demonstrate an in-depth knowledge and critical awareness of the legal and ethical aspects of lifecycle management of medicinal products. .

Skills and attributes

Successful students will typically:

• Demonstrate the ability to critically analyse the legal documentation considerations of maintaining and managing the brand through lifecycle management, including advertising and promotion, changing legal status and safety reporting
• Select and examine appropriate methods of communication of complex data regarding commercialised products for dissemination to both non-regulatory experts and regulatory experts, including the SmPC (summary of product characteristics) data
• Critically appraise and evaluate communications from regulatory bodies and research publications regarding commercialised medicinal products.

Focusing on lifecycle management? Consider:

• Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
• Module 7: Regulatory Strategy for Established Active Substances
• Module 8: Data for Abridged Applications and Specialised Products
• Module 10: Leadership and Strategic Management in Regulatory Affairs

Expanding your options? Consider:

• Module 2: Regulatory Strategy for a New Active Substance: Nonclinical Development
• Module 11: The US Regulatory Environment
• Module 12: Data Management and Digitalisation in Regulatory Affairs
• Module 19: Regulation of In vitro Diagnostic Medical Devices
• Module 18: Drug-device Combinations and Other Technologies

See the table below for the next planned dates for these modules.

Module schedule

The following table outlines the scheduling for all MSc modules through 2025.

Visit our Masterclasses page to see which modules are currently open for registration.