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DIA 2018 Global Annual Meeting

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

Update on Collaboration and Trends in Global Companion Diagnostics

    Session Chair(s)
      Karen D. Weiss, MD, MPH

      Karen D. Weiss, MD, MPH

      • Vice President, Global Regulatory Affairs
      • Janssen Pharmaceutical Companies of Johnson & Johnson, United States
    Regulatory representatives from Japan, US, and EU will discuss the latest trends and challenges they face in the area of companion diagnostics, and will also discuss potential collaboration opportunities and their value from the scientific and regulatory point of view.
    Learning Objective : (1) To share the latest trends in regulations related to companion diagnostics, and (2) To discuss common challenges and possible collaboration opportunities between Japan, the US, and EU
      Reiko  Yanagihara, PhD

      PMDA Perspectives on Companion Diagnostics Development in Japan

      Reiko Yanagihara, PhD

      • Deputy Review Director, Office of In Vitro Diagnostics
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Yun-Fu  Hu, PhD

      FDA Perspective

      Yun-Fu Hu, PhD

      • Deputy Director, Division of Molecular Genetics and Pathology, CDRH
      • FDA, United States
      Marie-Helene  Pinheiro, PharmD

      EMA Perspective

      Marie-Helene Pinheiro, PharmD

      • Industry Stakeholder Liaison, Corporate Stakeholders Department
      • European Medicines Agency (EMA), United Kingdom