Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)

This 3-hr virtual seminar on compliance processes for life science products in China will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

Why Should You Attend:

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.

Areas Covered in the Seminar:

• Country Profile / Healthcare System.
• Key Country Information.
• Strategic Considerations: Why China? / Asia Structure / Hub Locations.
• Governmental & Regulatory Authorities / Agencies / Structure.
• Company Establishment; Licenses & Key Personnel.
• Partner Companies / Local Relationship Options.
• In-Country Operational Considerations; Importance of Local Distributors
• Requirements to Conduct Clinical trials / Approvals / GCP
• Licensing Products ( Innovative Drugs , Generics / Similars, Orphan Drugs, Biologics / Vaccines, Medical Devices).