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Session 2 / Venue 4: Effective Consultation Strategy in the Global Development Based on Consultation Examples of Japan and Other Regions
Session Chair(s)
Fumi Yamamoto
Councilor for Pharmaceutical Affairs, Minister’s Secretariat
Ministry of Health, Labour and Welfare (MHLW), Japan
While the global development is advanced, global clinical trials has become one of the most important choices of development strategy. However, many hurdles are existed when performing global clinical trials in fact. To get over hurdles and/or to reduce hurdles, it has been the important point in the development strategy that develops a consultation strategy taking into account the order or consultation items. In this session, based on some examples that have been approved by global clinical trials etc., consultation strategy with regulatory authorities of foreign countries, challenges to be solved and points to consider for consultation items are presented from point of view of PMDA and companies. After that, a better consultation strategy and regulatory development strategy will be discussed.
Speaker(s)
Actual Case of Regulatory Authority Meetings Conducted Simultaneously in Japan, the US and the EU
Kaoru Masuda
Beigene Japan GK, Japan
Regulatory Strategy Group 2, Regulatory Affairs
Consultation Strategy with Health Authorities in Global Simultaneous Development
Eiko Tomita, MBA
Bristol-Myers K.K., Japan
Senior Executive Officer, Vice President, Global Regulatory Sciences Japan
Regulatory View Based on Amassed Cases of Global Clinical Trial Consultation
Naoyuki Yabana, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of In Vitro Diagnostics
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