The China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations) is a webinar that covers topics such as:
- Key Country Information
- Country Profile / Healthcare System
- Governmental & Regulatory Authorities / Agencies / Structure
- Strategic Considerations: Why China? / Asia Structure / Hub Locations
- Partner Companies / Local Relationship Options
- Company Establishment; Licenses & Key Personnel
- Requirements to Conduct Clinical trials / Approvals / GCP
- In-Country Operational Considerations; Importance of Local Distributors
- Variations and Amendments to Licenses
- Licensing Products ( Innovative Drugs , Generics / Similars, Orphan Drugs, Biologics / Vaccines, Medical Devices)
- Packaging and Labeling
- GMP and Inspections
- Reimbursement
- Price Establishment
- Taxes / Duties
- Import / Export / Customs Clearance
- Vigilance Reporting / Post-Marketing Requirements
- Advertising & Promotion
- Local Customs / Cultural Issues / Establishing Business Relationships
- Patents & Trademarks
- Conclusions
- Working with Local Agencies / Authorities
The China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations) brings together:
- Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant
- Quality, Regulatory, Global Business Development and General Management personnel whose responsibilities require knowledge of China`s regulatory, Manufacturing, quality and import / export requirements
- 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
