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Sunday, June 26 • 1:00pm - 4:30pm
#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-510-L04-P; CME 3.25; IACET 3.25; RN 3.25

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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 Japanese drug development with East Asian and global drug development, accelerated approval pathways (sakigake; regenerative medicine), orphan drug regulation and J-NDA review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

Who should attend?

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

Learning Objectives

• 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.

avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, PAREXEL International
Alberto Grignolo, PhD is Corporate VP, Global Strategy at PAREXEL Consulting, where he has worked for 24 years in various regulatory, drug development and management capacities. Most recently he relocated to PAREXEL's Tokyo Office for two years, establishing a new consulting unit there. He is currently engaged in initiatives that address clients' most significant opportunities and challenges in product development and commercialization. He is the... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama is currently Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for pharmacoepidemiological safety assessment and regulatory science research relating to new drug review and safety measure. He is also a rapporteur of ICH E17 (MRCTs) expert working group.

Sunday June 26, 2016 1:00pm - 4:30pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA