Latin America – Understanding Regulatory Compliance Requirements Across The Life Science Industry: 2-day In-Person Seminar

By: Robert J. Russell, President of RJR Consulting, Inc.
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Course Description:

This Latin America Regulatory compliance requirement seminar will cover topics across the full life-cycle of company & product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Why You Should Attend:

This regulatory compliance seminar specifically will focus on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, 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.

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.
  • 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.

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
  • 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
  • Use of Expert Reports
  • Package Inserts
  • Labeling Requirements
  • Amendments / Variations / Renewals
  • Fees
  • Daily Recap & Review of Upcoming Day 2 Agenda
Day Two (8:30 AM – 4:30 PM)
  • Marketing Authorization Processes
    • Generic Products & Bioequivalence Testing
    • Biologics & Biosimilars
    • Orphan Drug Special Processes
    • Compassionate Use / Special Access
  • Medical Device Registrations & Product Licenses
  • Device Classifications
  • Test Standards & Certifications
  • Amendments / Variations
  • Device Renewal Applications
  • Drug / Device Master File (DMF): Use in Latin America
  • 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: Day 2 Products
  • Drug / Device Vigilance & Post-Marketing Responsibilities
  • Import / Export Procedures
  • Patents / Copyrights / Trademarks
  • Advertising & Promotion of Products
  • Comparing and Contrasting Latin American Procedures vs. the U.S. FDA.
    • Comparison of Processes.
    • Agency Interactions
  • 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
    • Agency Interactions.
    • Business Impact Within and Outside Latin America.
    • Professionalism in Regulatory Lobbying.
  • Recent Country Legislation: New Regulations
  • Conclusions
  • Resources / Helpful Websites

Meet Your Instructor

Robert J Russell
Robert J. Russell
President of RJR Consulting, Inc.

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.

Venue

Location:
Buenos Aires, Argentina (Venue to be announced shortly)

October 23-24, 2014
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