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DIA 2018 Global Annual Meeting

Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations?

    Session Chair(s)
      William  Gregory, PhD

      William Gregory, PhD

      • Safety and Risk Management
      • Pfizer Inc, United States
    to be determined
    Learning Objective : 1. Describe the requirements for pre-market safety reporting in the U.S. 2. Describe the similarities and differences in global regulatory requirements for pre-market safety reporting 3. Recognize the value of streamlining the reporting process, including the creation of a global safety database
      Representative Invited

      Safety Reporting Practices: Current State, Efforts to Streamline the Process, and the Case for a Global Safety Database

      Representative Invited

      • FDA, United States
      Teiki  Iwaoka, PhD, MS

      Emerging New PV World: Comparison of and Exploring New Guidelines for Clinical Research in Japan

      Teiki Iwaoka, PhD, MS

      • Executive Consultant, Director of Drug Safety Outsourcing Planning
      • CAC Croit Corporation, Japan