1st Edition  Conference

Latin America: Regulatory Compliance Requirements for Life Science Products

"Understanding the Regulatory Process"
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.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.


  • Regulatory Overview (gov't offices, organization, info),Understanding the Regulatory Process
  • Amendments/Variations/Changes/Renewals,Marketing Authorizations/Registrations,Country Establishment
  • Summary of Product Characteristics,Registration documentation/CTD,Clinical Trial Application
  • Registration requirements,Pharmacovigilance/Post-marketing,Patents/Copyrights/Trademarks
  • mendments/Variations/Renewals,Comparing & Contrasting LA and US,Influencing the Regulatory Process


8:30 AM - 4:30 PM (Aug 29) (General)
8:30 AM - 4:30 PM (Aug 30) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details


20 Delegates
5 Exhibitors Estimated Count

Category & Type

Medical & Pharma
Education & Training


29-30 Aug 2019 Interested

Frequency Bi-annual

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Jay Polanco

Jay Polanco

Business Development Manager at Presspart Montevideo, Uruguay

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1699 USDAttendee Seminar One Registration
39.953000 -75.165000

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Venue to be announced

Philadelphia, USA

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