How does the Japanese regulatory system impact on local and global drug development strategies?

Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development:
June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for professionals in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan. 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 PMDA and Ministry of Health, MHLW, regulatory procedures during drug development, the integration of Japan drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review.

Instructor:
Alberto Grignolo, PhD
Corporate Vice President, Global Strategy and Services
PAREXEL Consulting, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.