3-hr Virtual Seminar: South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam
Thursday, November 21, 2013 from 10:00 AM to 1:00 PM (PST)
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.
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.
- 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
- QA/ QC
- Manufacturing/ Production
- Global Business Development
- Senior Management
This training will benefit personnel whose responsibilities require knowledge of South East Asian countries' regulatory, clinical, quality and import / export requirements.
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.