Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II

It is essential for Life science companies doing business in Latin America to know regulatory compliance requirements and procedures in Latin America. Specifically how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies.

ComplianceOnline brings to you a pack of 2 courses which covers topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined.

Part 1:

Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I

The Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

Areas Covered in the Webinar:

• Glossary of Terms.
• Defining the Opportunity.
• Country Facts: Argentina, Brazil, Mexico.
• Latin America's Regulatory Structure for the Life Science Product Industries.
• Mercosur - Southern Common Market.
• Beginning Your Company Involvement in Latin America: Examples of Country Requirements.
• Registration / Required Country Licenses.
• Common Fees.
• Overview of the Rules Governing Medicinal Products & Medical Devices.
  • Select Examples of:Clinical Trials, GCP, GMP, Specials, Marketing Authorizations, Product Classifications, Scientific Advice, Generics Pricing, Patents, Labeling, SPC, Variations, Manufacturing Licenses, Renewals, Pharmacovigilance, Orphan Drugs.
• Comparing & Contrasting Latin America with U.S. FDA.
• Getting Engaged with the Regulatory Process.
• Summary.
• Contact Points / Follow-Up.

Part 2:

Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry Part II

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America.

Areas Covered in the Webinar:

• Marketing Authorization Processes - Filings & Registrations.
  • Drug vs. Medical Device vs. Biologic vs. Combination Product.
• Drug Master File (DMF) Use in Latin America.
• Similar Products & Devices.
• Use of Expert Reports.
• Labeling Requirements.
• Processing Variations on Licensed Products.
  • Variations: Changes to Marketed Products
  • Types of Variations
  • Dossier Maintenance Expectations
  • Changes Concerning Manufacturing Aspects (Product & Process)
• Labeling & Packaging Leaflet Requirements.
• Orphan Drugs / Rare Diseases.
• Comparing and Contrasting Latin American Procedures vs. the U.S. FDA.
  • Comparison of Processes
  • Agency Interactions
  • Accepted Practices
• How and When to Influence the Regulatory Process.
  • Accepted Country Practices
  • Effective Monitoring Activity
  • Association vs. Individual Company Involvement & Intervention
• The Regulatory Negotiation Process.
  • Effective Approaches
  • The Do's and Don'ts of Regulatory Involvement
• How to Use Regulations / Regulatory Contacts to Your Advantage.
  • Check-in Procedure
  • Agency Interactions
  • Business Impact Within and Outside Latin America
  • Professionalism in Regulatory Lobbying
• Resources / Helpful Websites.

Panelist Profiles:
Robert J. Russell, For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.