Course Overview

The European pharmaceutical framework is undergoing the most significant overhaul in two decades. The proposed EU Pharmaceutical Legislation reform, published in April 2023, redefines market authorisation, incentives, manufacturing oversight, and access rules. The European Parliament and the EU Council have reviewed the proposals and reached political agreement on the reform, with the final legislative package expected to be formally adopted and enter into force during 2026. The UK MHRA continues to diverge post-Brexit, developing distinct regulatory pathways, reliance procedures, and pharmacovigilance frameworks. This masterclass delivers an in-depth, comparative and implementation-focused overview of these developments — enabling professionals to anticipate compliance impacts, adapt internal SOPs, and ensure regulatory agility across both the EU and UK markets.

Learning Objectives

• Interpret and apply key provisions of the new EU Pharmaceutical Legislation (Directive & Regulation).
• Align internal regulatory, quality, and PV processes with upcoming implementation timelines.
• Understand UK MHRA regulatory trends and how they differ from EU frameworks.
• Manage dual compliance challenges for companies operating in both EU and UK.
• Build forward-looking strategies for lifecycle, data, and transparency compliance.