South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam 2015

Topics

• Key Country Information
• Country Profile / Healthcare System
• Governmental & Regulatory Authorities / Agencies / Structure
• Strategic Considerations: Why focus on this country? / 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
• 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

Personnel in Medical Devices, Pharmaceuticals, and Combination Products manufacturing companies, including:

• Regulatory Affairs Professionals
• Clinical Trial/ Research Professionals
• Manufacturing/ Production
• QA/ QC
• Senior Management
• Global Business Development