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Evolution and Harmonization of First-in-Human Guidelines
Session Chair(s)
William B. Smith, MD
CEO
Alliance for Multispecialty Research, LLC , United States
Revised EMA guidelines for first-in-human studies have been issued. This forum will include a discussion on the significant differences between EMA and FDA guidelines and will include representatives from industry, CRO, and sites.
Learning Objective : Describe the changes suggested by EMA and FDA with first-in-human guidelines; Describe strategies for implementing these changes.
Speaker(s)
Changes to First-in-Human Studies Following the 2017 Revision of the EMA Guidance on Risks for FiH and Early Clinical Trials
Mattheus Paulus van Iersel, MD
PRA Health Sciences, Netherlands
Senior Director, Scientific Affairs - Clinical Pharmacology
Industry Perspective
William Angus, PHD
Biogen, United States
Principal Scientist, Toxicology
Industry Perspective
Sarah Robertson, PHARMD
Vertex Pharmaceuticals, United States
Senior Director, Clinical Pharmacology