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Understanding and Applying the ICH E17 Guideline on Multiregional Clinical Trials (MRCT): A Regulator’s and Industry Perspective
Session Chair(s)
Henrik K. Nielsen, PHD, MBA, MSC
Vice President
Novo Nordisk A/S, Denmark
Understanding and applying the ICH E17 guideline on Multiregional Clinical Trials (MRCT): A regulator’s and industry Perspective: Are you unsure about what E17 means for your clinical trials? Come and hear from industry and regulator experts who were involved in drafting the ICH E17 guidelines and developing the relevant training materials. Examples and case studies will be provided.
Learning Objective : Participants will understand the back-ground and implementation of the key challenges in planning and designing MRCTs. This will be achieved by hearing from people directly involved in drafting the ICH E17 and implementing the guideline, as well as case examples on pooling and consistency of treatment effect
Speaker(s)
Regulator's Perspective
I-Chun Lai, MD, MS
Center for Drug Evaluation, Taiwan, Taiwan
Senior Director, Division of Consultation
Industry Perspective
Romi Singh, PHD
Northeastern University, United States
Professor of Practice, Regulatory Sciences
Case Example: Evaluating Consistency of Treatment Effect as in a Cardio-Vascular Outcome Trial (LEADER) and Regulatory Implications
Henrik K. Nielsen, PHD, MBA, MSC
Novo Nordisk A/S, Denmark
Vice President