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Recent Advancement of the Pharmaceutical Inspection Cooperation Scheme and Good Manufacturing Practices in the Asia Pacific Region
Session Chair(s)
Chih-Hwa Wallace Lin, PhD
Researcher and Acting Director, Biotechnology Unit
Board of Science and Technology, Executive Yuan, ROC, Taiwan
Asia Pacific nations such as China, Japan, and Taiwan invest heavily in good manufacturing practices (GMP). Taiwan has recently joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for GMP. China has a new version of GMP regulations. The session will discuss the advancement of GMP in Asia and the impacts on industry.
Learning Objective : Discuss the advancement of good manufacturing practices (GMP) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP in the Asia Pacific region; Compare the development of GMP among Asian countries such as China, Japan, Korea, and Taiwan; Describe the impact on regulatory affairs and on industry.
Speaker(s)
TFDA Point of View
Ming-kung Yeh, PhD
TFDA, Taiwan
Director-General
PMDA Point of View
Takashi Nagashima
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
GMP Expert, Office of GMP/QMS Inspection
Industry Perspective
Michael Cutter
Novartis Pharma AG, Switzerland
Senior Director, Group Compliance and Auditing
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