#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development Day & Time:
June 15, 8:30AM - 12:00PM (Pacific Standard Time)Room Number:
Alberto Grignolo, PhD
Corporate Vice President, Global Strategy
PAREXEL Consulting, United States
Yoshiaki Uyama, PhD
Director, Division of Epidemiology, Office of Safety I
Pharmaceuticals and Medical Devices Agency (PMDA), JapanDescription:Maximize your learning while attending the DIA 2014 50th Annual Meeting! Receive $100 off of your DIA 2014 meeting registration by registering for two half-day tutorials or one full-day tutorial. Purchases must be made at the same time in order to receive the discount.
Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (Consultations with PMDA and Clinical Trial Notifications), the integration of Japan drug development with East Asian and global drug development, orphan drug regulation, and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected postapproval requirements, will be discussed.
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At the conclusion of this tutorial, participants should be able to:
• Explain the major elements of the Japanese regulatory system;
• Describe the regulatory procedures during development, registration, and post-approval;
• Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.
This tutorial is designed for professionals in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.