Understanding Clinical Trials Regulations in Latin America

Instructor: Tatiana Vogel
Product ID: 701626
  • Duration: 72 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2010

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This Clinical Trials Regulations in Latin America training will review the applicable Regulatory Process in the main Latin American countries where Clinical Research is developed, identifying opportunities to speed protocol approval in these countries.

Why Should You Attend:
Latin America is one of the top emerging markets in Clinical Trials, showing double digit growth in the number of studies it executes, high enrollment rates and quality levels comparable or better that those shown by sites in the US. The main challenge that the implementation of Clinical Trials in Latin America faces, is the lengthy and complex Regulatory process. In order to properly take advantage of the benefits this region has to offer in the field of Clinical Research, it is key to have a thorough understanding of the Regulatory process involved in each country, in order to speed protocol approval as much as possible.

This session will review in detail the Regulatory Process applicable for the main contributing countries in the region (Argentina, Brazil, Mexico, Chile, PerĂº, Colombia), covering documentation requirements, process flows, timelines and opportunities for an improved performance.

Areas Covered in the Seminar:

  • Overview of the Latin American region.
  • Clinical Trials Activitiy in the Latin American countries.
  • Regulatory Process for countries in Latin America.
  • Review of the overall regulatory process, including Ethiscs Committee and Ministry of Health approvals.
  • Main Opportunitites for speeding protocol approval in Latin America.
  • Documentation requirements, process flows, timelines and best practices.

Who Will Benefit:

This session will provide valuable assistance to the Pharmaceutical, Biotech and CRO Businesses involved in the management of clinical trials, with interest in expanding their activity to Latin America, including representatives such as:
  • Research Directors
  • Clinical Study Managers
  • Regulatory Affairs Directors/Managers
  • Project Directors/Managers

Instructor Profile:
Tatiana Vogel, Ph., is a Clinical Research Consultant with 15 years of experience managing Clinical Trials; including clinical operations, project management , data management and regulatory in the leading countries in Latin America.

Tatiana provides clinical trials Consulting Services to several CROs in Latin America and was formerly Assoc. Director of Research Operations in Latin America for Merck & Co.

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CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA
Upcoming In-person Seminars by EX-FDA OFFICIALS

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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