DIA
Drug Information Association Logo

#40: Understanding and Navigating the Regulatory System in China

Tutorial name:
#40: Understanding and Navigating the Regulatory System in China

Day & Time:
June 24, 9:00AM - 5:00PM

Room Number:
119B

Description:
Maximize your learning while attending the DIA 2012 Annual Meeting! Receive $100 off of your DIA 2012 meeting registration by registering for two half day tutorials (#20-34) or one full day tutorial (#40-48). Purchases must be made at the same time in order to receive the discount.

This tutorial will provide an overview of the regulatory system in China, including the agencies and institutions at the central government and provincial levels, as well as their roles and responsibilities. Various regulations for product registration, clinical trials, and safety reporting will be presented, and the regulatory pathways and strategic considerations for clinical trial and marketing applications will be discussed. A step-by-step roadmap of how to navigate the regulatory system in China for clinical trial approval and product registration will also be discussed. This discussion will include key points to consider, strategies, and tactics.

Target Audience:
This tutorial is designed for professionals involved in regulatory affairs, clinical research, pharmacovigilance/drug safety, project management, R&D strategies, and quality assurance and quality control.

© 2015 DIA