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

Training CD

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

Customer Care

Fax: +1-650-963-2556


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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