China & Pacific Rim Markets : Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

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.

Other Pacific Rim markets are also growing in importance and interest in access to innovative products. In-country Regulatory Agencies are progressing in their sophistication, process development and regulatory requirements.