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Global Perspective on ICH E8(R1): General Considerations for Clinical Trials
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, Science and Regulatory Advocacy , 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
Vice President, R&D Quality and Risk Management, GlaxoSmithKline, United States
Panelist
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER, FDA, United States
Panelist
Vice President, Head Global Regulatory Strategy, Vertex Pharmaceuticals, United States
EMA Update
Head of Division International Affairs, European Medicines Agency, Netherlands
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