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東京ビッグサイト

2017年11月12日 (日) 午前 9:30 - 2017年11月14日 (火) 午後 5:30

〒135-0063, 東京都江東区有明3-11-1

第14回DIA日本年会

[V4-S4] Are the Drugs Appropriately Reaching to the Pediatrics in Needs? - Current Development Status and Future Steps of Pediatric Drugs in Japan -

Session Chair(s)

Natsuko  Hamada

Natsuko Hamada

Senior Regulatory Scientist, Therapeutic Area Regulatory,

Eli Lilly Japan K.K., Japan

While drug-lag is being solved with the advance in Global drug development, currently, development of pediatric drugs in Japan is lagging behind. The development of pediatric drugs is ongoing in EMA under PIP (Pediatric Investigation Plan), and in FDA under PSP (Pediatric Study Plan). Now that Global drug development including Japan is becoming a main stream, a discussion has started for Japan to join in Global drug development also for pediatric drugs. In US and Europe, over 10 years have passed since the development of pediatric drugs (PSP, PIP) were promoted by the national governments. With Addendum to ICH E11 is currently at Step3, upon receiving future prospects in Japan from MHLW and PMDA, this session will hold a progressive discussion on promoting the development of pediatric drugs in Japan from government-industry-academia stance, respectively.

Speaker(s)

Masakatsu  Imoto

New Approach for Pediatric Medicines in Japan

Masakatsu Imoto

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Masao  Nakagawa, MD

The Role of Japan Pediatric Society for Promotion of Pediatric Drug Development

Masao Nakagawa, MD

Japan Pediatric Society, Japan

Masakazu  Hirata, MD, PhD

Pediatric Drug Development in Japan and International Regulatory Collaboration

Masakazu Hirata, MD, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Clinical Reviewer, Division of RS Consultation, Kansai Branch

Katsuaki  Sato

Katsuaki Sato

GlaxoSmithKline K.K., Japan

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