Sign Up

Your Profile will be reviewed by Admin
TODAY : Advance Search
Apr 2015


Courtyard Newark Downtown 858 Broad Street Newark , New Jersey 07102
Tel: (973) 848-0070
Google Map

Compliance Processes for Life Science Products in Brazil, Russia, India, China Markets


Course Description:

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.

Learning Objectives:

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

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.

For Registration


Note: Use coupon code 232082 and get 10% off on registration.



MORE events +