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DIA 2018 Global Annual Meeting

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

Expedited E2B 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
    FDA has provided guidance to sponsors on systematic approaches to IND safety reporting that focus on informative reports of important safety information. To enhance the efficiency of this process, FDA has initiated a pilot program for the submission of IND safety reports in a standardized, structured format that follows the ICH E2B standard (with certain regional modifications). Likewise, for expedited clinical trial safety reports in Japan and elsewhere. This forum is designed to provide a balanced discussion of clinical trial electronic case reporting requirements based on audience interest. The forum will include lessons learned from the ongoing US pilot and a comparison with the clinical trials reporting situation in Japan. Each of the expert panel members will provide brief introductory comments and, at the conclusion of prepared remarks, the panel will entertain Q&A.
    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
      Tamy  Kim, PharmD

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

      Tamy Kim, PharmD

      • Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER
      • 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

      • Director, Pharmacovigilance, Clinical Development
      • Nanocarrier Co., Ltd., Japan
      Ta-Jen  Chen, MS

      Directional Roadmap for ICSR Data Standards and Harmonized Case Reporting

      Ta-Jen Chen, MS

      • Project Management Officer, OSP, CDER
      • FDA, United States
      Suranjan  De, MBA, MS

      FAERS II

      Suranjan De, MBA, MS

      • Deputy Director, Regulatory Science, OSE, CDER
      • FDA, United States
      Dieter  Kempf, MS

      Industry Perspective

      Dieter Kempf, MS

      • Head, Pharmacovigilance Information and Systems
      • Genentech, A Member of the Roche Group, United States