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

Instructor:

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.