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

  • 2021 (Not Final)
  • United States

Description

Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs) is a virtual training through WebEx that covers topics such as:

  • Latin America`s Regulatory Structure for the Life Science Product Industries
  • Defining the Opportunity
  • Glossary of Terms
  • Country Facts: Argentina, Brazil, Mexico
  • Beginning Your Company Involvement in Latin America: Examples of Country Requirements
  • Mercosur - Southern Common Market
  • Common Fees
  • Registration / Required Country Licenses
  • Marketing Authorization Processes - Filings & Registrations
  • Overview of the Rules Governing Medicinal Products & Medical Devices
  • Use of Expert Reports
  • Drug Master File (DMF) Use in Latin America Registrations
  • Labeling & Packaging Leaflet Requirements
  • Processing Variations on Licensed Products
  • Comparing and Contrasting Latin American Procedures vs. the U.S. FDA
  • Orphan Drugs / Rare Diseases
  • The Regulatory Negotiation Process
  • How and When to Influence the Regulatory Process
  • Resources / Helpful Websites
  • How to Use Regulations / Regulatory Contacts to Your Advantage

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

Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs) might be held in United States in 2021 (Not Final).

More Details

Prices:
1699 US Dollar
Organizer:
ComplianceOnline
Website:

Future Events

  • Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs) - 2021, United States (67397)

Past Events

  • Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Focus: Brazil, Mexico, Argentina) - 18 May 2020, Webinar (22128)
  • Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) - 29-30 Aug 2019, Philadelphia, PA, United States (40799)
  • Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) 2018 - 14-15 Jun 2018, Courtyard New Orleans French Quarter/Iberville, New Orleans, LA, United States (32718)
  • Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) 2017 - 09-10 Nov 2017, San Diego, CA, United States (17501)

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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