#50: Understanding and Navigating the Regulatory System in ChinaDay & Time:
June 23, 9:00AM - 5:00PMRoom Number:
256Description:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 meeting registration by registering for two half day tutorials or one full day tutorial. 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.
|#50: Understanding and Navigating the Reg Sys in C||IACET||6.50||0.700|
At the conclusion of this tutorial, participants should be able to:
- Describe the regulatory system in China, including the agencies and institutions and their roles and responsibilities in the regulatory processes for clinical trial and registration approval, as well as safety reporting
- Explain the history and the recent changes in the regulatory system in China and future perspectives
- Describe the regulatory pathways and strategic considerations for successful clinical trial and marketing applications in China
- Discuss how to navigate the regulatory system in China for clinical trial approval and product registration.
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.