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Regulatory Perspectives in the Execution of Clinical Studies and Medical Product Commercialization in Asia Pacific
Session Chair(s)
Karen Jaffe
Consultant, United States
Regulatory Perspective on Co-Development of Drugs and Companion Diagnostics in Japan, US, and EU
Learning Objective : Discuss the regulatory framework and the role of ICH, IMDRF, AHWP, and regional harmonization in Asia Pacific; Explore the impact to global development from the perspectives of regulatory agencies and industry; Discuss how to develop drugs with companion diagnostics communicating with global regulatory authorities (PMDA, FDA and EMA).
Speaker(s)
Lost in Translation: Conducting Device Trials in Asia
Karen Jaffe
Consultant, United States
Regulatory Perspective on Co-Development of Drugs and Companion Diagnostics in Japan, US, and EU
Sumimasa Nagai, MD, PhD
Kyoto University Hospital, Japan
Institute for Advancement of Clinical and Translational Science(iACT)
Evolution and Recent Reformation of Regulatory Framework of Medical Devices in Asia Pacific
Chih-Hwa Wallace Lin, PhD
Board of Science and Technology, Executive Yuan, ROC, Taiwan
Researcher and Acting Director, Biotechnology Unit
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