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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)
Mattheus Paulus van Iersel, MD
Senior Director, Scientific Affairs - Clinical Pharmacology, PRA Health Sciences, Netherlands
William Angus, PHD
Principal Scientist, Toxicology, Biogen, United States
Sarah Robertson, PHARMD
Senior Director, Clinical Pharmacology, Vertex Pharmaceuticals, United States
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