DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/phhvg2/compliance) has announced the addition of the "Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations" conference to their offering.
This course will be beneficial to Regulatory, Quality, Clinical, Manufacturing, Supply Chain, Global Business Development and General Management personnel whose responsibilities require knowledge of these Emerging Market's regulatory, quality and import / export requirements. Additionally, administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant.
Global business development and general management requiring an understanding of how regulations and compliance issues must be followed in finding a local distributor / partner, setting up a company office or establishing local or contract manufacturing facility will profit from attending.
Why Should You Attend:
The BRIC nations, as they are known (Brazil, Russia, India and China) have been improving the sophistication of their regulatory regime governing the food and Life Science products industry in recent years. This has included amending GMP ,GLP, GCP, GSP and other regulations allowing their country policies to further align with international standards of practice.
This better alignment will assist the growth in these markets for new and already licensed products. For manufacturers and distributors of Life Science Products in these emerging markets, it is important to pay close attention to the pace at which their Healthcare Agencies implement these changes. Manufacturers and distributors must in turn add this knowledge and adjust their standard operating procedures when necessary to ensure compliance with the evolving regimes.
Areas Covered In The Session:
- The Nation's Regulatory Structure.
- Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
- 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
- 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
- The current key regulations effecting product development and your company's product pipeline
- Product Licensing / or Registration; Licensing differences across Product Types
- Pricing establishment
- Healthcare Insurance systems and reimbursement
- Understanding the local concerns and specific challenges in working with each country's Regulatory Authority
- Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding each market to your company's global market presence
- Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package
- Strategies for streamlining the registration application process for faster approval
- Maintenance on Authorized Products
- License Renewals
- Import / export; Licenses and Supply Chain considerations
For more information visit http://www.researchandmarkets.com/research/phhvg2/compliance