概要
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The globalization of the pharmaceutical industry means that it is no longer enough for regulatory and development staff and managers in Japanese pharmaceutical companies to understand only the Japanese regulations and process of drug development.
It is now essential for professionals in the field to understand the regulations, processes, and trends in other countries that participate in global drug development.
For several years DIA has offered a training course in the US focused on submission of IND/NDA to the FDA. The course is very popular with attendees from around the world, including Japanese participants. With this success, DIA has brought the course to Japan since 2012. The training features:
• Focus on regulations and processes (IND and NDA)
• How to work productively and efficiently with FDA
• Plus More
The trainers will be Dr. Alberto Grignolo and Dr. Carol H Danielson, who are two of the original FDA IND/NDA trainers in the US. The course will be conducted in English except that Workshops will be conducted in Japanese for a deeper understanding.
プログラム委員会
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Masayoshi Higuchi Head of Quality & Regulatory Compliance Unit,
Chugai Pharmaceutical Co., Ltd., Japan -
Akiko Ikeda, RPh Associate Director, Regulatory Development Dept.
Janssen Pharmaceutical K.K., Japan -
Yumi Inukai New Drug Regulatory Affairs Dept.
Daiichi Sankyo Co., Ltd., Japan -
Miyuki Kaneko Japan Regulatory Portfolio Lead, Regulatory Affairs
Pfizer R&D Japan G.K., Japan -
Yomei Matsuoka, MSc, RPh Vice President, Pharmacoepidemiology and PMS Department
Daiichi Sankyo Co., Ltd., Japan -
Miwa Tamada Manager, New Drug RA Department, Regulatory Affairs
GlaxoSmithKline K.K., Japan
