Spring Intro 2023

30/03/2023

Other EU initiatives running in parallel

EU Health Union Package • Three open consultations concerning the legislative proposals the Commission presented as part of the European Health Union. EC Beating Cancer Action Plan • The plans sets out actions to support, coordinate or supplement Member state's efforts in all key stages of the disease EMA Regulatory Science Strategy • March 2020, EMA published its Regulatory Science Strategy to 2025 • The first tangible output of the EMAs strategy is Project DARWIN - Data Analysis and Real-World Interrogation Network European Medicines Agencies Network Strategy • The EMA & HMA Joint Strategy looks into six strategic focus areas which will aligned with EC Pharma Sci Strat

The Organisation for Professionals in Regulatory Affairs

105

Regulatory is and Will continue to be key to effective

drug development and product registration

MAA

Phase 1 Phase 2 Phase 3

Post Approval

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

106