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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)
PMDA Perspectives on Companion Diagnostics Development in Japan
Mari Shirotani, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office Director, Office of Advanced Evaluation with Electronic Data
FDA Perspective
Yun-Fu Hu, PHD
FDA, United States
Deputy Director, Division of Molecular Genetics and Pathology, CDRH
EMA Perspective
Marie-Helene Pinheiro, PHARMD
European Medicines Agency, Netherlands
Industry Stakeholder Liaison, Corporate Stakeholders Department