Module 7 - Regulatory Strategy for Established Active Substances - 7FHH1145

Regulatory Strategy for Established Active Substances

Next course: November/December 2022

Students will consider and evaluate practical aspects of regulatory strategy for established active substances. They will explore and critically debate the regulatory issues likely to arise in order to provide effective advice.

Overall the module was very good and well organised."

Overview

This module enables regulatory professionals to further their understanding of all aspects of the regulations and the strategic issues to be considered in relation to medicines containing established active substances, including line extensions, generics and the relevant aspects for over-the-counter (OTC) products.

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Display systematic understanding and critical awareness of the strategies for approval of established active substances in the context of abridged applications and OTC products
• Have a critical understanding of the regulatory requirements, directives and associated documentation associated with established active substance approval
• Demonstrate a conceptual understanding of the legal requirements for approval of established medicinal products, such as OTC products, to evaluate critically current research within a theoretical framework.

Skills and attributes

Successful students will typically:

• Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of established active substances
• Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding established active substances
• Critically appraise and evaluate communications from regulatory bodies and research publications regarding established active substances.

Focusing on established products and lifecycle management? Consider:

• Module 6: Regulatory Strategy: From Development to the Market Place
• 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 5: Regulatory Control of Clinical Operations
• Module 11: The US Regulatory Environment
• Module 12: Data Management and Digitalisation in Regulatory Affairs
• 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.