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#20: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development

Tutorial name:
#20: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development

Day & Time:
June 24, 8:30AM - 12:00PM

Room Number:
124

Description:
Maximize your learning while attending the DIA 2012 Annual Meeting! Receive $100 off of your DIA 2012 meeting registration by registering for two half day tutorials (#20-34) or one full day tutorial (#40-48). Purchases must be made at the same time in order to receive the discount.

Major changes in Japanese pharmaceutical regulations are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major elements of the regulatory system including the Pharmaceuticals and Medical Devices Agency (PMDA), regulatory processes during development (consultations), and J-CTD review. Several development strategies necessary to meet Japanese requirements for new drug approval will be identified. Postmarket surveillance and pricing reimbursement processes will be reviewed, and finally, the impact of the changing regulatory system on global strategies will be identified throughout development, registration, and postmarket stages.

Learning Objective(s):
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 multinational 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.

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