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Sunday, June 24 • 1:00pm - 4:30pm
#34: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-510-L04-P; CME 3.25; IACET 3.25; RN 3.25

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.
An additional registration fee is required for all preconference short courses.
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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 specific attributes of the Japanese regulatory system and their impact on local and global development strategies



Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →


Sunday June 24, 2018 1:00pm - 4:30pm
Room 159 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  • format json
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial