This seminar will help you understand the regulatory, quality and import / export requirements for Life Science Products in emerging markets – Brazil, Russia, India and China.
Improved alignment to global standards was an important step forward toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies. Healthcare Authorities and regulatory systems have now made their requirements and procedures more transparent to industry partners. Clinical Trials can be conducted at a fraction of the expense.
Structured healthcare systems and insurance coverage is now more prevalent among these emerging nation populations and predictions for growth of Rx and OTC products is impressive in these relatively untapped markets.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Brazil, Russia, India and China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators review filings and registrations and what is expected in the authorization and dossier maintenance of licensed products throughout their life.
Understanding cultural norms, establishing relationships and protecting your intellectual property will also be discussed and these will need to be integrated into your company training and corporate business strategies.
This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in these emerging markets. It will provide training on:
- 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
Who will Benefit:
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.
- Regulatory Affairs
- Supply Chain
- Import / Export
- Global Business Development
- General Management
- Administrative Staff
Topic Back Ground:
More than ever, the World has become one integrated market for conducting Global Clinical Research and for expanding the market for pharmaceuticals, biologics, medical devices and combination products. The time and expense of bringing new products to market continue to challenge budgets and existing balance sheets. While it is necessary to continue to have a robust pipeline of new patented products, global producers have been evaluating how best to begin participating in the emerging markets of Brazil, Russia, India and China. Manufacturers are looking to tap into the huge population areas of the World and bring innovative products to these patient populations. Taking products which already have existing country licenses and expanding these licenses into BRIC nations is proving to be an effective strategy for those who have begun.
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.