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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)
Karen Jaffe
, Consultant, United States
Lost in Translation: Conducting Device Trials in Asia
Sumimasa Nagai, MD, PHD
Institute for Advancement of Clinical and Translational Science(iACT), Kyoto University Hospital, Japan
Regulatory Perspective on Co-Development of Drugs and Companion Diagnostics in Japan, US, and EU
Chih-Hwa Wallace Lin, PHD
Researcher and Acting Director, Biotechnology Unit, Board of Science and Technology, Executive Yuan, ROC, Taiwan
Evolution and Recent Reformation of Regulatory Framework of Medical Devices in Asia Pacific
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