China's Regulatory Agencies & Regulatory Compliance Requirements - Parts I & II

2-Session Live Web Training:
Session 1: Tuesday, August 17, 2010
Session 2: Tuesday, August 24, 2010
(1:20 p.m. – 3:45 p.m. EDT)
(12:20 p.m. – 2:45 p.m. CDT)
(10:20 a.m. – 12:45 p.m. PDT)
Instructor: Robert J. Russell

Introduction: (Click here for Agenda based on  North American & International Time Zones)

This course will specifically focus on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China, and will cover topics relating to pre-clinical and clinical requirements, as well as addressing the structure of their regulatory agencies. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations, and what is expected in the authorization and dossier maintenance of licensed products.

The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues, which have caused difficulties for Life Sciences firms, will also be discussed. Course content will explain how China’s GCP and GMP interact with and utilize ICH standards and how they relate with other national regulatory agencies, in addition to how personnel can best address the conflicts that sometimes arise and the approaches that can best be taken for resolution.

This live and interactive two-session BenAstrum web training course will be useful for sales and general management personnel who require an overview of the Regulatory Compliance requirements within China and how best to consider the country into one’s business strategy.

Learning Benefits

This course is designed to provide an overview of the regulatory environment in China and will provide training in:

• The Regulatory Structure in China
• Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
• How to begin company involvement in China
• How current regulations effect product development strategies
• Pricing issues
• Understanding the concerns/issues of Chinese Regulatory Personnel
• Understanding the Local Culture: How to negotiate with the regulators
• Information necessary for effective submissions
• Strategies for streamlining the registration application process for faster approval
• Maintenance of Authorized Products

Course Agenda

1. Country Profile/Healthcare System
2. Key Country Information
3. Strategic Considerations: Why China?/Asia Structure/Hub Locations
4. Governmental & Regulatory Authorities/Agencies/Structure
5. Company Establishment; Licenses & Key Personnel
6. Partner Companies/Local Relationship Options
7. In-Country Operational Considerations; Importance of Local Distributors
8. Requirements to Conduct Clinical trials/Approvals/GCP
9. Licensing Products

• Innovative Drugs
• Generics/Similars
• Orphan Drugs
• Biologics/Vaccines
• Medical Devices

1. Variations and Amendments to Licenses
2. GMP and Inspections
3. Packaging and Labeling
4. Price Establishment
5. Reimbursement
6. Import/Export/Customs Clearance
7. Taxes/Duties
8. Advertising & Promotion
9. Vigilance Reporting/Post-Marketing Requirements
10. Patents & Trademarks
11. Local Customs/Cultural Issues/Establishing Business Relationships
12. Working with Local Agencies/Authorities
13. Conclusions

Who Should Attend

This course will be of benefit to regulatory personnel whose responsibilities require knowledge of China’s regulatory environment. Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant. Any sales and general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.