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Thursday, June 16 • 8:00am - 11:00am
41A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

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Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-22-508-L04-P ; CME 2.75; IACET 2.75; RN 2.75

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

Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides

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Who should attend?

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.

Learning Objectives

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



Speakers
YA

Yoshitaka Ando

Senior Director, Reguratory & Access Consulting, Parexel International, Japan
Andy has 25 years of pharmaceutical and CRO industry experience. He has supported a numbers of small biotech start-up companies to global pharmaceutical companies to make their regulatory strategy in Japan and facilitated PMDA consultation meetings. He and his team also prepare eCTD... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for all epidemiological activities in PMDA including the projects of MIHARI(Medical Information for risk assessment... Read More →


Thursday June 16, 2022 8:00am - 11:00am CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial