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14th DIA Japan Annual Meeting 2017

[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

      • Regulatory Scientist, Therapeutic Area Regulatory, Japan Regulatory Affairs
      • 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.
      Masakatsu  Imoto

      New Approach for Pediatric Medicines in Japan

      Masakatsu Imoto

      • Director, Research and Development Division, Health Policy Bureau
      • Ministry of Health, Labour and Welfare (MHLW), 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, PhD

      Pediatric Drug Development in Japan and International Regulatory Collaboration

      Masakazu Hirata, PhD

      • Review Director, Office of Cellular and Tissue-based Products
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Katsuaki  Sato

      Katsuaki Sato

      • GlaxoSmithKline K.K., Japan

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313