mardi 26 janvier 2021

Two Day Course: China & Pacific Rim Markets: Compliance Processes for Life Science Products – (Philadelphia, PA, United States – August 23-24, 2018) –

Par Rédaction , dans Communiqués , le 10 août 2018

Friday, August 10th 2018 at 10:21am UTC

& Pacific Rim Markets: Compliance Processes for Life Science Products –
Company Establishment, Clinical Trials, Registrations, Renewals and
Supply Chain Considerations »
conference has been added to’s

This China & Pacific Rim life science compliance-based seminar will
discuss the regulatory structure and requirements for compliance with
in-country regulations for Pharmaceuticals, Medical Devices, Biologics
and Combination Products.

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 &
the Pacific Rim.

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.

Other Pacific Rim markets are also growing in importance and interest in
access to innovative products. In-country Regulatory Agencies are
progressing in their sophistication, process development and regulatory

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.

It will provide training on:

  • 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.

For more information about this conference visit

Laura Wood, Senior Manager
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900
Topics: Biotechnology,
, Supply
Chain Management

Source: Research and Markets

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