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ICH 30th Anniversary Series: Harmonizing Global Requirements for Clinical Trials
Session Chair(s)
Amanda Marie Roache, MS
Senior Director, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (PhRMA), United States
This session will provide an overview of ICH efficacy topics instrumental to the harmonization of pharmaceutical development standards and an introduction to the new and revised topics that are currently underway. We will also discuss how ICH Guidelines apply now more than ever, in the time of a global pandemic. Additionally, an overview will be presented of ICH's GCP Renovation plan to provide updated guidance to address the increasing diversity of study types and data sources that support regulatory and other health policy decisions.
Learning Objective : Discuss the role of ICH efficacy topics in harmonizing standards for more efficient pharmaceutical development and registration; Understand how ICH Guidelines help support drug development in the time of a global pandemic; Explain current ICH Guidelines being revised, new Guidelines being developed, and their anticipated impact to pharmaceutical development.
Speaker(s)
Revision of ICH E6 Good Clinical Practices
M. Khair ElZarrad, PhD, MPH
FDA, United States
Director, Office of Medical Policy, CDER
Revision of ICH E8 General Consideration for Clinical Studies
Joanne Palmisano, MD, FACP
Vertex Pharmaceuticals, United States
Vice President, Head Global Regulatory Strategy
ICH E11A Pediatric Extrapolation
Lynne Yao, MD
FDA, United States
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
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