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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

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

13th DIA Japan Annual Meeting 2016

[V5-S5] Educational Session: Comparison of Review Processes by PMDA/FDA/EMA - For Successful Global Simultaneous Submission

Session Chair(s)

Akiko  Ikeda, RPh

Akiko Ikeda, RPh

KalVista Pharmaceuticals Japan K.K., Japan

The global simultaneous drug development has become common in recent years, and it is important to develop drugs while understanding situations in Japan as well as in foreign countries. Therefore, we would like to focus on the review processes, and compare them in Japan, Europe, and the US, explaining their differences. In addition, instructors will explain the basics of consideration points for early approval based on examples of the actual reviews. We believe it is possible to achieve rapid review and early approval by understanding each review process.

Speaker(s)

Masayoshi  Higuchi

Comparison of Review Processes by PMDA/FDA/EMA for Successful Global Simultaneous Submission

Masayoshi Higuchi

Chugai Pharmaceutical Co., Ltd., Japan

Head of Quality & Regulatory Compliance Unit,

Miyuki  Kaneko

Comparison of Review Processes by PMDA/FDA/EMA for Successful Global Simultaneous Submission

Miyuki Kaneko

Pfizer R&D Japan G.K., Japan

Japan Regulatory Portfolio Lead, Regulatory Affairs

Sheetal  Agarwal, PhD, RAC

Comparison of Review Processes by PMDA/FDA/EMA for Successful Global Simultaneous Submission

Sheetal Agarwal, PhD, RAC

PAREXEL Consulting, United States

Principal Consultant

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