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14th DIA Japan Annual Meeting 2017

[V7-S6] Future of Development Strategy and Lifecycle Management in Asia after ICH Q12 Guideline Implementation

    Session Chair(s)
      Yukio  Hiyama, PhD

      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.
      Yasuhiro  Kishioka, PhD

      ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective

      Yasuhiro Kishioka, PhD

      • Principal Reviewer, Office of Cellular and Tissue-based Products
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Yang  Wang

      CFDA’s View on Implementation of ICH Q12 as well as Current Quality Compliance System such as PQS in China

      Yang Wang

      • Senior Reviewer
      • Center for Drug Evaluation, China Food and Drug Administration, China
      Tomonori  Nakagawa

      Pharmaceutical Quality System and Change Management Expectation to ICH Q12 from Industry

      Tomonori Nakagawa

      • Production HQ Manufacturing Process Development Department (API)
      • Otsuka Pharmaceutical Co., Ltd., Japan

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313