Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2015

Topics

• 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

Who should Attend

Representatives from:

• Quality
• Regulatory Affairs
• Manufacturing
• Clinical
• Import / Export
• Supply Chain
• General Management
• Global Business Development
• Administrative Staff