#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical DevelopmentDay & Time:
June 23, 8:30AM - 12:00PMInstructor(s):
Alberto Grignolo, PhD
Corporate Vice President, Global Strategy and Services
PAREXEL Consulting, United StatesDescription:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 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 post-approval 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 processes during development, registration and postapproval
• Discuss specific attributes in the Japanese regulatory system and their impact on local and global development strategies. Target Audience:
This tutorial is designed for professionals in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.