DUBLIN, April 19, 2018 /PRNewswire/ --
The "Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar " conference has been added to ResearchAndMarkets.com's offering.
This two-day comprehensive course 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.
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.
Agenda
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 ProcessRegulatory 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
For more information about this conference visit https://www.researchandmarkets.com/research/ww978r/2_day_seminar?w=5
Media Contact:
Research and Markets
Laura Wood, Senior Manager
[email protected]
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
SOURCE Research and Markets
Related Links
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
Newsrooms &
Influencers
Digital Media
Outlets
Journalists
Opted In
Share this article