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Global Perspective on ICH E8(R1): General Considerations 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
Experts from the ICH E8(R1) working group provide an overview of the revisions to the ICH E8(R1) guideline on General Considerations for Clinical Studies and discuss how the revised guideline will support improved study design and conduct.
Learning Objective : Discuss how the revised ICH E8 Guideline on General Considerations for Clinical Studies will modernize guidance for clinical study design; Describe how to identify critical-to-quality factors to support the meaningfulness and reliability of clinical study results; Discuss how the revised guideline will address a broader range of study designs and data sources.
Speaker(s)
Panelist
Kerstin Koenig, PhD, MSc
Bristol Myers Squibb, United States
Vice President, Research and Development Quality
Panelist
Mark Levenson, PhD
FDA, United States
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
Panelist
Joanne Palmisano, MD, FACP
Vertex Pharmaceuticals, United States
Vice President, Head Global Regulatory Strategy
EMA Update
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
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