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