Recorded Date: June 2005
Course Type: Recorded On-line Seminar
Speakers:
Kristen DeVito, Associate Director, Project Management, Quintiles Clinical Supplies
Michael T. Sweeney, Director, Development & Compliance, World Courier
Latin America continues to present an exciting range of opportunities for the clinical trials community. Given the regulatory complexities within the region, advanced planning is critical in order to ensure the timely delivery of clinical trial materials (CTM) to investigator sites. This Recorded On-line Seminar provides insight on how to avoid common delays that can prevent protocols from progressing as planned. This Recorded On-line Seminar provides an overview of regulatory information on labeling, CTAs, and import/export, including logistical considerations in the distribution of CTM to various Latin American countries.
The following topics are covered:
- Why Conduct Trials In Latin America?
- Packaging And Labeling Considerations
- Export Authorization Requirements
- Country Specific Import Considerations
- General Shipping Considerations
- Depots
- Returns And Reconciliation
Learning Objectives
At the end of this Recorded On-line Seminar, participants will:
- Have a basic understanding of some of the requirements and timelines for clinical trial supplies in Latin America
- Understand how to overcome challenges by planning ahead
Who Should Attend
- CTM professionals who are involved in the design, planning, manufacture, packaging and labeling and distribution of clinical trial materials.
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