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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
Director of Regulatory Policy and Intelligence, AbbVie, 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)
Catherine Cohet, PHD
Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Establishing Value and Enabling Use of RWE to Support Regulatory Decisions: Focus on European and International Collaborations
Daniel Rosenberg, PHD
Senior Director Global Epidemiology, Johnson & Johnson, Switzerland
ICH M14 Guidance and Industry Perspective on International Collaboration and Use of RWE for Regulatory Purpose
Kelly Robinson, MSC
Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
International Coalition of Medicines Regulatory Authorities Real-World Evidence and Observational Studies Working Group: Lessons Learned and Path Forward
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Panelist
Peter Mol, PHARMD, PHD
CHMP member, NL, MEB, Netherlands
Panelist
Kenichi Tamiya, MSC, RPH
Associate Executive Director, Office of New Drug, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Panelist
Christine Dehn
Manager Patient Representation & EU Affairs, Deutsche Herzstiftung e.V., Germany
Panelist - Patient Representative
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