Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2015 is a seminar that covers topics such as:
- The specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
- The Nation`s Regulatory Structure
- Clinical Trials: When are Clinical Trials needed? When are they not? Healthcare Authority requirements, the Application Process, Ethics Committee approval, CRO Selection and Start-up
- How to begin your company`s involvement in each country (Brazil, Russia, India, China): local licenses, in-country personnel required and facilities required or contracted
- Product Licensing / or Registration; Licensing differences across Product Types
- The current key regulations effecting product development and your company`s product pipeline
- Healthcare Insurance systems and reimbursement
- Pricing establishment
- Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding each market to your company`s global market presence
- Understanding the local concerns and specific challenges in working with each country`s Regulatory Authority
- 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
- License Renewals
- Maintenance on Authorized Products
- Import / export; Licenses and Supply Chain considerations
Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2015 brings together representatives from:
- Quality
- Regulatory Affairs
- Manufacturing
- Clinical
- Import / Export
- Supply Chain
- General Management
- Global Business Development
- Administrative Staff
