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Sunday, June 18 • 1:00pm - 4:30pm
#33: 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: 0286-0000-17-508-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.

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 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... Read More →


Sunday June 18, 2017 1:00pm - 4:30pm
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial