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ICH E17 Guideline on Multi-Regional Clinical Trials: A Catalyst for Simultaneous Global Development and Registration
Session Chair(s)
Julie O'Brien, PHD
Head Europe and International Regulatory Policy
Pfizer, Ireland
Explore the current situation with regards to implementation of ICH E17 guideline on MRCT, from regulatory authority and industry point of view. What are the key barriers to full use of the guideline internationally and how can these be addressed?
Learning Objective : Analyze pain points to implementation of ICH E17; Identify best practices for successful implementation globally; Demonstrate the important role of applying ICH E17 principles for global development and near-simultaneous registration.
Speaker(s)
Role of E17 in Simultaneous Global Development, a Regulator's View
Yoko Aoi, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Coordination Director - Office of Review Management
Industry Perspective: EFPIA Membership Survey on E17 Implementation, Barriers, Training Needs and Pooling Strategies
Henrik K. Nielsen, PHD, MBA, MSC
Novo Nordisk A/S, Denmark
Vice President
Panelist
Fergus Sweeney, PHD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
Role of Real World Evidence in Multi-Regional Clinical Trials
Barbara E Bierer, MD
Harvard Medical School, United States
Faculty Director, MRCT Center; Professor of Medicine
Panelist
Tomas Salmonson, DrMed, PHD
Critical Path Institute, Netherlands