China & Pacific Rim Markets: Compliance Processes for Life Science Products

This China & Pacific Rim life science compliance-based seminar will discuss the regulatory structure and requirements for compliance with in-country regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

This China & Pacific Rim life science compliance-based seminar will discuss the regulatory structure and requirements for compliance with in-country regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products. China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which SFDA implements these changes and to make changes to their standard operating procedures when necessary to ensure compliance with the evolving regime.

Learning Objectives:
This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products (pharmaceuticals, medical devices, biologics, combination products) as an importer into China & the Pacific Rim. It will provide training on:

• The current Regulatory Structure.
• Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
• How to begin your company’s involvement in-country: local licenses, personnel and facilities required.
• Clinical Trials: Why consider Country X? CTA requirements, the Application Process, CRO Selection and Start-up.