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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.


Evolution and Harmonization of First-in-Human Guidelines

    Session Chair(s)
      William B. Smith, MD

      William B. Smith, MD

      • CEO
      • Alliance for Multispecialty Research/NOCCR, 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
      William  Angus, PhD

      Industry Perspective

      William Angus, PhD

      • Principal Scientist, Toxicology
      • Biogen, United States
      Sarah  Robertson, PharmD

      Industry Perspective

      Sarah Robertson, PharmD

      • Senior Director, Clinical Pharmacology
      • Vertex Pharmaceuticals, United States