Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico 2017

  • 14 Feb 2017
  • Webinar

Description

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico 2017 is a webinar that covers topics such as:

  • Defining the Opportunity: Overview of Latin America
  • Glossary of Terms
  • Latin America`s Regulatory Structure for the Life Science Product Industries
  • Country Facts: Argentina, Brazil, Mexico
  • Mexico – COFEPRIS Structure & Insight to Operations
  • Brazil – ANVISA Structure & Insight to Operations
  • Mercosur - Southern Common Market
  • Argentina – ANMAT Structure & Insight to Operations
  • Beginning Your Company Involvement in Latin America: Examples of Country Requirements
  • Harmonization Efforts
  • Common Fees
  • Registration / Required Country Licenses
  • Clinical Trials, GCP: When are they needed?
  • Overview of the Rules Governing Medicinal Products & Medical Devices
  • Stability Studies: Zonal Unique Requirements
  • GMP Compliance
  • CTD Format Transition
  • Marketing Authorization Process & Dossier Requirements: Pharmaceuticals
  • Package Inserts
  • Summary of Product Characteristics
  • Amendments / Variations / Renewals
  • Labeling Requirements
  • Medical Device Registrations & Product Licenses
  • Marketing Authorization Processes
  • Amendments / Variations
  • Device Classifications
  • Drug / Device Master File (DMF): Use in Latin America
  • Device Renewal Applications
  • Labeling & Packaging Leaflet Requirements
  • Processing Variations on Licensed Products
  • Import / Export Procedures
  • Drug / Device Vigilance & Post-Marketing Responsibilities
  • Advertising & Promotion of Products
  • Patents / Copyrights / Trademarks
  • The Regulatory Negotiation Process
  • How and When to Influence the Regulatory Process
  • Recent Country Legislation: New Regulations
  • How to Use Regulations / Regulatory Contacts to Your Advantage
  • Resources / Helpful Websites
  • Conclusions

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico 2017 is intended for:

  • Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant
  • Regulatory personnel whose responsibilities require knowledge of Latin America’s regulatory environment
  • Global Supply Chain personnel
  • QA / QC Personnel
  • Manufacturing personnel
  • Clinical / Pharma & Device personnel
  • Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit
  • Global Business Development personnel

Past Events

Important

Please, check "Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance, Logistics, Quality assurance, Risk Management
Health & Medicine: Medical device, Medical laboratories, Medical technology, Pharma

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