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[V5-S5] With the Aim of Developing Pediatric Drugs Being Triggered by Japan
Session Chair(s)
Fumiaki Kobayashi, PhD
President
CTD inc., Japan
The Pediatric investigation plan (PIP) became effective in EU in 2007 in order to accelerate the development of drugs for pediatric. The plan of clinical trials of children should be considered during conducting the clinical trials for adults, in general. In Japan, the re-examination period of the approval drugs is expanded by conducting clinical trials for pediatric use. However, starting development of drugs for pediatric use in parallel with development of drugs for adults is not working well. Recently, Japan has increased opportunities to join global pediatric studies in parallel with clinical trials for adults. However, Japan should join the discussion of global development strategy for pediatric drugs in the early stage. This session will cover the current status and issues of development of pediatric drugs in Japan with speakers from pharmaceutical industry, regulatory agencies and academia. In addition, we will discuss development strategy of pediatric drugs being triggered by Japan, on the basis of an industry-government–academia cooperation for development of pediatric drugs in EU/US.
Speaker(s)
Current Status of Pediatric Drug Development: Pharmaceutical Industry Viewpoints
Takeshi Nakanishi
GlaxoSmithKline K.K., Japan
Department Manager, New Drug RA Department, Regulatory Affairs
Development of Pediatric Drugs in Japan: Regulatory Viewpoints
Mayumi Iwata-Okada, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principle Reviewer, Office of Vaccines and Blood Products
How Can We Facilitate the Drug Development in Children? View from the Academia.
Hidefumi Nakamura, MD, PhD
National Center for Child Health and Development, Japan
Director for Clinical R&D,
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