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DIA 2018 Global Annual Meeting


Evolution and Harmonization of First-in-Human Guidelines

    Session Chair(s)
      William B. Smith, MD

      William B. Smith, MD

      • President
      • 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.
    Speaker(s)
      Mattheus Paulus Van Iersel, MD

      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

      • Senior Director, Scientific Affairs - Clinical Pharmacology
      • PRA Health Sciences, Netherlands
      Michael  Rothenberg, MD, PhD

      Industry Perspective

      Michael Rothenberg, MD, PhD

      • Safety Science Leader. Early Development (LEAD) Safety
      • Genentech, A Member of the Roche Group, United States
      Representative Invited

      FDA Perspective

      Representative Invited

      • FDA, United States