ComplianceOnline, Online Event
2013-02-21
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.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in listed South East Asian Countries. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Learning Objectives: This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products as an importer into South East Asia. It will provide training on: - The current Regulatory Structure.
- Understanding the specific procedures.
- How to begin your company’s involvement in-country: local licenses, personnel and facilities required.
- Clinical Trials: Why consider Country X? CTA requirements, the Application Process, CRO Selection and Start-up.
- The current key regulations effecting product development and your company’s product pipeline.
- Pricing establishment.
- Understanding the local concerns and specific challenges in working with Local Regulatory Personnel.
- Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding South East Asian countries to your company’s global market presence.
- Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package.
- Strategies for streamlining the registration application process for faster approval.
- Maintenance of Authorized Products.
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
- Manufacturing/ Production
- Global Business Development
- Senior Management
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