China - Compliance Processes For Life Science Products
Why Should You Attend:
Why Should You Attend:
China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which SFDA implements these changes and to make changes to their standard operating procedures when necessary to ensure compliance with the evolving regime.
This 3 hrs course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. Content will also include descriptions of the methods by which regulators in the SFDA 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 (pharmaceuticals, medical devices, biologics, combination products) as an importer into China. It will provide training on:
- The Regulatory Structure in China.
- Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
- How to begin your companys involvement in China: local licenses, personnel and facilities required.
- Clinical Trials: Why China? SFDAs requirements, the Application Process, CRO Selection and Start-up.
- The current key regulations effecting product development and your companys product pipeline.
- Pricing establishment.
- Understanding the local concerns and specific challenges in working with Chinese Regulatory Personnel.
- Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding China to your companys 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 the Seminar:
- Country Profile / Healthcare System.
- Key Country Information.
- Strategic Considerations: Why China? / 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 ( Innovative Drugs , Generics / Similars, Orphan Drugs, - Biologics / Vaccines, Medical Devices).
- 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.
Who Will Benefit:
This course will be beneficial to:
Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require knowledge of Chinas regulatory, quality and import / export requirements
Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant
Global business development and general management requiring an understanding of how regulations and compliance issues are culturally handled along with how best to consider China into ones Global Business Strategy will profit from attending
Instructor Profile:
Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.
by: ComplianceOnline
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