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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Japanese healthcare arena presents promising business opportunities, but regulatory professionals may face unique challenges in successfully launching products. RAPS professionals have compiled the definitive guide for working on healthcare products for the Japanese market. This reference provides a comprehensive source of information to drive successful market access for drugs, biologics, medical devices and in vitro diagnostic products.
Whether you need a brief overview or a thorough analysis of the regulatory system in Japan, you will find this volume an indispensable addition to your professional library.
Also, the chapter “Roadmap to Japan,” a new addition to the Second Edition, navigates readers through the entire product launch and product lifecycle management process from the regulatory professional’s’ point of view. The new content makes the Second Edition a must-read book for business leaders in Japan and at corporate headquarters as well.
To purchase this publication locally, please visit Yakuji Nippo, LTD at www.yakuji.co.jp.
Whether you are a newcomer to the Japanese regulatory market or a senior professional, Fundamentals of Japanese Regulatory Affairs, Second Edition, gives you vital insight to drive regulatory and business excellence.
Check out our Fundamentals Series.