China & Pacific Rim Markets: Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2019

January 24-25, 2019
San Francisco

China & Pacific Rim Markets: Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2019 will be held in San Francisco, CA, United States on January 24-25, 2019.

China & Pacific Rim Markets: Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2019 is a conference dedicated to this China & Pacific Rim life science compliance-based seminar will discuss the regulatory structure and requirements.

China & Pacific Rim Markets: Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2019 covers topics such as:

  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
  • The current Regulatory Structure.
  • Clinical Trials: Why consider Country X? CTA requirements, the Application Process, CRO Selection and Start-up.
  • How to begin your company’s involvement in-country: local licenses, personnel and facilities required.
  • Pricing establishment.
  • The current key regulations effecting product development and your company`s product pipeline.
  • 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.
  • Understanding the local concerns and specific challenges in working with Local Regulatory Personnel.
  • Strategies for streamlining the registration application process for faster approval.
  • Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package.
  • Maintenance of Authorized Products.

China & Pacific Rim Markets: Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2019 brings together:

  • Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant
  • Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require local knowledge of regulatory, quality and import / export requirements
  • 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 & the Pacific Rim into one`s Global Business Strategy will profit from attending

Venue (View Map)

San Francisco,
California,
United States
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1699 US Dollar
No exhibition

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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