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TOC Ariake Convention Hall

Apr 13, 2016 9:00 AM - Apr 14, 2016 6:00 PM

3-5-7 Ariake, , Koto-ku, Tokyo, 135-0063 Japan

10th DIA Asia New Drug Conference in Japan

The registrants will have access to presentation PDFs through Thursday, October 13, 2016.

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Special Session: Collaboration for Better Drug Development - Future Perspective on International Collaboration through ICH, APEC, etc. as a draft idea -

Session Chair(s)

Tatsuo Kurokawa, DIAFellow, PhD

Tatsuo Kurokawa, DIAFellow, PhD

Director General, The Japan Biosimilar Association, Japan

As a result of a rapid globalization in the new drug development, clinical trials are being conducted in a lot of countries. In addition, consistent global packages data including the clinical trials are being reviewed there. Demand has been increasing for globally harmonized, science-based standards for the drug development and evaluation of the medical products. Such consistent standards will improve the transparency and efficiency of the drug development and evaluation process and, ultimately, provide new innovative drugs to patients around the world promptly. Global regulatory initiatives such as ICH has supported to reduce the development times and streamline the regulatory assessment process through harmonized guidelines. Recently non-ICH countries/regions actively participate in guideline development and implement ICH’s strategies and China also shows great interest. Other examples of regulatory collaboration include Asian regulatory training center to share PMDA’s knowledge and experience in product reviews. This session will address current status and future prospects of regulatory collaboration.

Speaker(s)

Junko Sato, PhD

Contribution of PMDA to the Capacity Building - Establishment of Asia Training Center -

Junko Sato, PhD

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Hironobu Saito, PhD

Overview of ICH Reform Explanation

Hironobu Saito, PhD

Corporate Officer /Head of Medical Affairs Div., DaiiachiSankyo, Japan

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