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China & Pacific Rim Markets : Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations  

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Seminar Summary:

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China and the listed Pacific Rim Countries. (see full course description)

 
 

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Training Course Syllabus:


Course Description

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China and the listed Pacific Rim Countries* (Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand). The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.


Learning Objectives:

  • The current Regulatory Structure.

  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

  • 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 China and countries from the Pacific Rim 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.
  • Topic Back Ground:

    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.


    DAY 1 - CHINA(8:30 AM - 4:30 PM)

    8:30 – 9:00 AM: Registration
    9:00 AM: Session Start Time
    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 (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.

    DAY 2 - A HIGH-LEVEL REVIEW OF FOLLOWING TOPICS FOR TAIWAN, HONG KONG, SINGAPORE, MALAYSIA, VIETNAM & THAILAND(8:30 AM - 4:30 PM)


    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 (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.

    Seminar Summary:

    This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China and the listed Pacific Rim Countries. (see full course description)

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