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Who should attend Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment, QA / QC Personnel, Global Supply Chain personnel, Clinical / Pharma & Device personnel, Manufacturing personnel, Global Business Development personnel
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Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment, QA / QC Personnel, Global Supply Chain personnel, Clinical / Pharma & Device personnel, Manufacturing personnel, Global Business Development personnel

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Seminar Summary:

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America (see full course description)

 
 
 

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Training Course Syllabus:


Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) - Regulatory Compliance Training Seminar


Course Description:

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.


Why You Should Attend

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics 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 pre-clinical and clinical requirements, as well as, addressing 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 the wide array 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 Healthcare Authorities. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.


Course Outline:

Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

LA Overview
LA markets
Harmonization efforts
Understanding the Regulatory Process
Regulatory Overview (gov't offices, organization, contact info)
Brazil - ANVISA
Mexico – COFEPRIS
Argentina – ANMAT
Country Establishment
Clinical Trials
Clinical Trial Start-up
Clinical Trial Application
IND's
Reporting
GCP
Scientific advice
Stability studies
Pharmaceuticals
Marketing Authorizations/Registrations
Registration requirements
Registration documentation/CTD
Summary of Product Characteristics
Package insert
Labeling
Pharmacovigilance/Post-marketing
Amendments/Variations/Changes/Renewals
Fees
Submission Process
Paper filings
Electronic filings

Day Two (8:30 AM – 4:30 PM)

Generics & Bioequivalence
Biologics
Compassionate use
Orphan drugs
Medical Devices
Device Classification
Testing Standards
Registrations
Amendments/Variations/Renewals
Cost build-up model
Fees
Post-marketing
Combination products
Patents/Copyrights/Trademarks
Import/Export procedures
Tax exemptions
Advertising/Promotion
Comparing & Contrasting LA and US
Challenges in Latin America
Influencing the Regulatory Process
Conclusions & summary

Seminar Summary:

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America (see full course description)

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