Evolution and Harmonization of First-in-Human Guidelines
William B. Smith, MD
VRG/NOCCR, An AMR Company, 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 : • Identify the significant changes in the revised EMA guideline; EMEA/CHMP/SWP/28367/07 Rev. 1.
• Summarize feedback of sponsors, authorities and clinical sites on the changed recommendations.
• Describe how these recommendations can be implemented in the designs of First-in-Human studies.
Changes to First-in-Human Studies Following the 2017 Revision of the EMA Guidance on Risks for FiH and Early Clinical Trials