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Preconference Workshops

Pharmaceuticals

Preconference Workshop: EU Pharmaceutical Regulatory Reform

Tuesday, May 13, 2025
08:30 - 16:00 CEST
Location: Studio 202 (level 2)
Learning Level: Advanced Ticketed Event
Current EU Pharmaceutical Regulatory Reforms include the General Pharmaceutical Legislation (GPL) revision and HTA Regulation implementation while newly proposed legislation includes a Critical Medicines Act and a Biotech Act. These signal the continued focus on the EU's life science sector by the European Commission. However, the road is often long between legislative text proposals to full implementation of framework changes. As the underpinning pharmaceutical legislation nears the trilogue discussion stage what will be needed to ensure a smooth implementation for all stakeholders?

The draft texts introduce sweeping changes impacting the current 20-year-old framework. This workshop will provide an overview of the key changes proposed in the General Pharmaceutical Legislation and explore with participants implementation strategies and timelines.

Key GPL Revision Elements to be Discussed:
• Lifecycle Regulatory Framework Changes: From revised R&D incentives and streamlined marketing authorization procedures to enhanced post-authorization requirements including pharmacovigilance and shortage prevention measures.
• Digital Transformation: Implementation of electronic product information (ePI), digital regulatory submissions, and new data infrastructure requirements across the pharmaceutical ecosystem.
• Stakeholder Impact

Assessment: Analysis of how the revised legislation will affect industry operations, regulatory authority resources, and patient access to medicines throughout the EU.

Discussion:
Panellists from the EC, health authorities, patient groups and industry will discuss topics such as:
• Which provisions will have the biggest impacts on current ways of working?
• With the revision impacting the whole of the medicines lifecycle, when and how should impacted stakeholders begin to undertake change management programs?
• What learnings can be taken from other medical product legislative updates to ensure a smooth implementation of GPL changes?
• How impacted stakeholders can work together to identify opportunities and challenges during the period of transition between legislative frameworks?

Learning Objectives:

  • Identify the critical changes in the General Pharmaceutical Legislation revision that will impact regulatory activities across the medicine lifecycle and develop strategies to address them.
  • Evaluate implementation considerations for different stakeholder groups and recognize key milestones for organizational readiness and compliance planning.
  • Apply lessons learned from previous legislative implementations to develop effective transition plans that minimize disruption while maximizing opportunities presented by the new framework.