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International Collaboration and Convergence on Guidance to Enable Real-World Evidence (RWE) for Regulatory Decision-Making
Session Chair(s)
Álmath Spooner, PhD
Head of Europe Regulatory Policy & Intelligence (RPI)
Ireland
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force
European Medicines Agency, Netherlands
International Collaboration and Convergence on Guidance to Enable Real-World Evidence (RWE) for Regulatory Decision-Making
Learning Objective : • To provide an update on international collaboration and convergence of guidance on real-world evidence (RWE) to strengthen regulatory decision-making for safer and more effective medicines. • To explore and debate on how multi-stakeholder collaboration can foster enhanced integration of RWE in regulatory decision-making.
Speaker(s)
Establishing Value and Enabling Use of RWE to Support Regulatory Decisions: Focus on European and International Collaborations
Catherine Cohet, PhD
European Medicines Agency, Netherlands
Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force
ICH M14 Guidance and Industry Perspective on International Collaboration and Use of RWE for Regulatory Purpose
Daniel Rosenberg, PhD
Johnson & Johnson, Switzerland
Senior Director Global Epidemiology
International Coalition of Medicines Regulatory Authorities Real-World Evidence and Observational Studies Working Group: Lessons Learned and Path Forward
Kelly Robinson, MSc
Health Canada, Canada
Director General, Marketed Health Products Directorate
Panelist
John Concato, MD, MPH, MS
FDA, United States
Associate Director for Real-World Evidence Analytics, OMP, CDER
Panelist
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
Panelist
Kenichi Tamiya, MSc, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director, Office of New Drug
Panelist - Patient Representative
Christine Dehn
Deutsche Herzstiftung e.V., Germany
Manager Patient Representation & EU Affairs
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