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Tokyo Big Sight

Nov 16, 2014 9:00 AM - Nov 18, 2014 6:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

11th Annual Meeting DIA Japan 2014

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Round Table: What are Expectations for “Adaptive Licensing"?

Session Chair(s)

Kazuhiko Mori, PhD, MSc

Kazuhiko Mori, PhD, MSc

Senior Managing Director

Japan Pharmaceutical Manufacturers Association (JPMA), Japan

Yoshihiko Ono, RPh

Yoshihiko Ono, RPh

Head of Regulatory Affairs

MSD K.K., Japan

Implementation of Adaptive Licensing in Europe

Speaker(s)

Francesco Pignatti, MD

Implementation of Adaptive Licensing in Europe

Francesco Pignatti, MD

European Medicines Agency, Netherlands

Scientific Adviser for Oncology

Daisaku Sato, PhD, MPharm, RPh

Perspective on the Regulatory Schema of the Adaptive Licensing for Pharmaceuticals

Daisaku Sato, PhD, MPharm, RPh

Ministry of Health, Labour and Welfare, Japan

Director, Compliance & Narcotics Division

Hiromichi Shirasawa, MD

Moving Forward To New Paradigm~ Adaptive Approach ~

Hiromichi Shirasawa, MD

MSD K.K., Japan

Vice President and Executive Officer, Head of Japan Development

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