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Virtual Event

2022 年 06 月 16 日 8:00 上午 - 2022 年 06 月 16 日 11:00 上午

(Eastern Standard Time)

Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

概览

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/ My Events


Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course 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 Japanese 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.

谁应该参加？

This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

学习目标

At the conclusion of this short course, 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 knowledge of core labeling implementation and deviations
  • Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies

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