Latin America Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)


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The Latin America Regulatory compliance requirement training/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 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.

Who Will Benefit:

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.

DAY 01(8:30 AM - 5:00 PM)

8:30 – 9:00 AM: Registration

9:00 AM: Session Start Time

  • 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 02(8:30 AM - 4:30 PM)

Session Start Time: 8:30 am

  • Marketing Authorization Processes
  • Generic Products & Bioequivalence Testing
  • Biologics & Biosimilars
  • Orphan Drug Special Processes
  • Compassionate Use / Special Access
  • Medical Device Registrations & Product requirements
  • IVD Registrations and Product requirements
  • Device / IVD Classifications
  • Test Standards & Certifications
  • Amendments / Variations
  • Device / IVD 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 / IVD 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.V
  • 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.
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Other Registration Option
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  2. Fill this form with attendee details & payment details
  3. Fax your PO to 1-888-883-7697 or,
  4. Email it to cs@compliance.world

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By Check -

Pay your check issued from the payee to "Redstone Learning Inc." (Our Parent Company) and mail the check to –
Compliance.world (Redstone Learning Inc.)
1180 Avenue of the Americas,
8th Floor, New York,
NY 10036

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