South East Asia Regulatory Compliance for Life Science Products, Live Webinar 2015 is a webinar that covers topics such as:
- 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
South East Asia Regulatory Compliance for Life Science Products, Live Webinar 2015 is intended for attendees from:
- Medical Devices
- Pharmaceuticals
- Combination Products manufacturing companies: