China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations) 2014

Key Topics

• 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

Who should Attend

• 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