3-hr Virtual Seminar - China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)

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 CFDA implements these changes and makes additional changes to their operating procedures when forming the nation-wide Agency in 2013.

This 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 CFDA 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 life-cycle 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 company’s involvement in China: local licenses, personnel and facilities required.
• Clinical Trials: Why China? CFDA’s 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 Chinese Regulatory Personnel.
• Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding China 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: Variations & Amendments to Licenses

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.
• Conclusions.

Note: A detailed, 6-hr training is available on the same topic. Email [email protected] for more information on the training CD.

Who Will Benefit:

This course will be beneficial to:

• Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require knowledge of China's 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 one's Global Business Strategy will profit from attending

Instructor Profile:

Mr. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Consumer Products and Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in Product Development, Global Business Development and Regulatory Compliance for pharmaceuticals, medical devices, consumer products, food and cosmetics manufacturers. The company has offices in Columbus, Ohio, Brussels, Belgium and Buenos Aires, Argentina and several satellite offices in the Asia / Pacific region where they interact with the global Ministries of Health and product Registration Agencies. Country establishment, product licensing and maintenance and license renewals are core competencies of our speaker. Mr. Russell has received a B.S. and M.S.in Chemistry.

Topic Background:

The Chinese government's establishment of a single drug regulatory authority in 2003 (The State Food and Drug Administration) was an important step toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies, centralized the Chinese healthcare regulatory system, and made it more transparent to industry partners. The SFDA now oversees all medications. Other former functions of the ministry have been assigned to different government bodies. The most important of these was the transfer of medical insurance responsibilities to the new Ministry of Labor and Social Security. The Ministry of Health retains its other main functions: regulatory development and oversight, healthcare resource allocation, and medical research and education.

Along with it in 2010, China has amended GMP, GLP, GCP, GSP and other regulations, China’s aim is to further align the country with international standards of practice. For manufacturers and distributors and importers of drugs and medical devices in China, it is imperative to pay close attention to the pace at which SFDA implements these changes. They have to make changes accordingly to their standard operating procedures so that they can ensure compliance quickly and effectively with the evolving regime.

In China, the SFDA was recently re-named the CFDA (The China Food & Drug Administration).

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