Why Should You Attend:
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, IVDs, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to full product life-cycle management, as well as, address 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.
Course Content
October 6th, 2021 (11:00 AM to 5:00 PM EDT)Seminar Agenda
- Glossary of Terms.
- Defining the Opportunity: Overview of Latin America
- Country Facts: Argentina, Brazil, Mexico.
- Latin America's Regulatory Structure for the Life Science Product Industries
- Brazil - ANVISA Structure & Insight to Operations
- Mexico - COFEPRIS Structure & Insight to Operations
- Argentina - ANMAT Structure & Insight to Operations
- Mercosur - Southern Common Market
- Harmonization Efforts
- 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.
- Clinical Trials, GCP: When are they needed?
- GMP Compliance
- Stability Studies: Zonal Unique Requirements
- Marketing Authorization Process & Dossier Requirements: Pharmaceuticals
- CTD Format Transition
- Summary of Product Characteristics
- Package Inserts
- Labeling Requirements
- Amendments/Variations/Renewals
- Marketing Authorization Processes
- Generic Products & Bioequivalence Testing
- Biologics & Biosimilars
- Orphan Drug Special Processes
- Compassionate Use/Special Access
- Medical Device Registrations & Product Licenses
- Device Classifications
- Amendments/Variations
- Device Renewal Applications
- Drug/Device Master File (DMF): Use in Latin America
- Processing Variations on Licensed Products.
- Labeling & Packaging Leaflet Requirements
- Drug/Device Vigilance & Post-Marketing Responsibilities
- Import/Export Procedures
- Patents/Copyrights/Trademarks
- Advertising & Promotion of Products
- How and When to Influence the Regulatory Process.
- The Regulatory Negotiation Process.
- How to Use Regulations/Regulatory Contacts to Your Advantage.
- Recent Country Legislation: New Regulations
- Conclusions
- Resources/Helpful Websites.
Course Provider
Robert J. Russell,
President/CEO ,
RJR Consulting, Inc.Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 19 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices. Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.
Who Should Attend
This course will be beneficial to:- 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.
- QA/QC Personnel
- Global Supply Chain personnel
- Clinical/Pharma & Device personnel
- Manufacturing personnel
- Global Business Development personnel
- Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.
