3-hr Virtual Seminar: South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam

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.

Note: Japan & South Korea are not covered as they are the subject of popular companion courses entitled: South Korea: Navigating the Regulatory and Clinical Trial Environment and Japan: Navigating the Regulatory and Clinical Trial Environment

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.
• Licensing Products
• Variations and Amendments to Licenses.
• GMP and Inspections.
• Packaging and Labeling.
• Price Establishment.
• Reimbursement.
• 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.
• Conclusions.

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
• QA/ QC