China & Pacific Rim Markets : Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2015 is a seminar that 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 2015 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
