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DIA 2021 Global Annual Meeting


Advancing Medicines’ Regulation in Europe: Key Strategies to 2025

Session Chair(s)

Jordi  Llinares Garcia, MS

Jordi Llinares Garcia, MS

  • Head of Research and Innovation
  • European Medicines Agency, Netherlands
The session covers the EMA regulatory science strategy and the European Medicines Agencies network strategy to 2025 and discusses how they contribute to address upcoming innovations and regulatory challenges in view of EU public health priorities. Join the Good Clinical Practices & Quality Assurance Community for a follow up round table discussion (session #251 RT L) on Tuesday, June 29, 3:00PM - 4:00PM EDT.
Learning Objective : Discuss the importance of having a regulatory science strategy in Europe and the main areas expected to advance medicines’ regulation to 2025; Identify the six strategic focus areas for the European Medicines Agencies Network Strategy (EMAN)to 2025; Describe how the EMAN can help deliver the priorities of the regulatory science strategy (RSS) and of the wider network’s priorities.

Speaker(s)

Karl  Broich, DrMed

Key Priorities of the European Medicines Agencies Network Strategy (EMANS) 2025

Karl Broich, DrMed

  • President
  • Federal Institute for Drugs and Medical Devices (BfArM), Germany
Peter Richard Arlett, MD, FFPM, FRCP

Regulatory Sciences: Leveraging Big Data and Real-World Evidence

Peter Richard Arlett, MD, FFPM, FRCP

  • Head Data Analytics and Methods Task Force
  • European Medicines Agency, Netherlands
Fergus  Sweeney, PhD

Clinical Trial Regulation and Advances in Clinical Trials

Fergus Sweeney, PhD

  • Head of Clinical Studies and Manufacturing Task Force
  • European Medicines Agency, Netherlands