This 3-hr training on South East Asia regulatory compliance for life science products will discuss the regulatory structure and requirements for compliance with in-country regulations for pharmaceuticals, medical devices, biologics and combination products. This webinar will focus on a high-level composite of requirements in Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand.
Why Should You Attend:
The South East Asian markets are growing in importance and interest in access to innovative products. In-country regulatory agencies are progressing in their sophistication, process development and regulatory requirements.
Areas Covered in this Webinar:
Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand
Country Profile / Healthcare System.
Key Country Information
Strategic Considerations: Why focus on this country? / 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.
Variations and Amendments to Licenses.
GMP and Inspections.
Packaging and Labeling.
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 the following personnel in Pharmaceuticals, Medical Devices, and Combination Products manufacturing companies:
Clinical Trial/ Research Professionals
Regulatory Affairs Professionals
Global Business Development
Added by complianceonlinecom on November 5, 2012