This China life science compliance based webinar will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations.
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.
- Price Establishment.
- 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
Note: ComplianceOnline provides 20% Discount on any Second purchase of Webinar