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  • 3-hr Virtual Seminar - China: Compliance Processes for Life
    Science Products

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Wednesday - Aug 07, 2013 10:00 AM
  • End Time:
  • Wednesday - Aug 07, 2013 01:00 PM
  • Location:
  • Online
  • This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

    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.

    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.
    - 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.
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