This Regulatory compliance training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela. The course will cover 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. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts which arise and the best course for resolution.
Areas Covered in the seminar:
- 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.
Who will benefit:
- Regulatory personnel whose responsibilities require knowledge of Latin America’s regulatory environment.
- Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.
- Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.
Instructor Profile:
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.
