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Update on Collaboration and Trends in Global Companion Diagnostics
Session Chair(s)
Karen D. Weiss, MD
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 : Describe the latest trends in regulations related to companion diagnostics; Discuss common challenges and possible global collaboration opportunities.
Speaker(s)
Mari Shirotani, PHD
Office Director, Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yun-Fu Hu, PHD
Deputy Director, Division of Molecular Genetics and Pathology, CDRH, FDA, United States
Marie-Helene Pinheiro, PHARMD
Industry Stakeholder Liaison, Corporate Stakeholders Department, European Medicines Agency, Netherlands
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