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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.
Navigating the complex waters of the Japanese regulatory market can be intimidating. With Terms & Definitions of Japanese Regulatory Affairs—the first book of its kind—regulatory professionals will find convenient and comprehensive definitions and English translations of the most important Japanese regulatory terms and acronyms.
Featuring entries selected for their relevance to the work of regulatory professionals across the Japanese market, this reference guide provides valuable insights from medicinal products, medical devices and beyond.
Who should use this publication?
This reference is a valuable resource for regulatory professionals who are new to—or transitioning into—the Japanese market.
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