This 90-minute China life science compliance based webinar 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).
Variations and Amendments to Licenses.
GMP and Inspections.
Packaging and Labeling.
Import / Export / Customs Clearance.
Taxes / Duties.
Advertising & Promotion.
Vigilance Reporting / Post-Marketing Requirements.
Patents & Trademarks.
Local Customs / Cultural Issues / Establishing Business Relationships.
Working with Local Agencies / Authorities.
Who Will Benefit:
This course will be beneficial to:
Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require knowledge of China's regulatory, quality and import / export requirements
Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant
Global business development and general management requiring an understanding of how regulations and compliance issues are culturally handled along with how best to consider China into one's Global Business Strategy will profit from attending
Added by complianceonlinecom on November 5, 2012