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[V7-S6] Future of Development Strategy and Lifecycle Management in Asia after ICH Q12 Guideline Implementation
Session Chair(s)
Yukio Hiyama, PhD
Visiting Researcher
National Institute of Health Sciences, Japan
For global pharmaceutical companies, the management of change control processes difference among the countries is one of the factors that prevent continuous improvements and innovations. The ICH Q12 guideline “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”, that is currently under consideration, provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner. Regulators and companies from Asia will present the challenges toward ICH Q12 guideline implementation and the changes in the drug development strategy in their countries.
Speaker(s)
ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective
Yasuhiro Kishioka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer Director, Office of Cellular and Tissue-based Products
CFDA’s View on Implementation of ICH Q12 as well as Current Quality Compliance System such as PQS in China
Yang Wang
Center for Drug Evaluation, China Food and Drug Administration, China
Senior Reviewer
Pharmaceutical Quality System and Change Management Expectation to ICH Q12 from Industry
Tomonori Nakagawa
Otsuka Pharmaceutical Co., Ltd., Japan
Production HQ Manufacturing Process Development Department (API)