This session will examine several regulatory issues that impact US and global trial operations from multiple perspectives. Topics include US and Latin American trial issues, OTC drugs and personal care products used in clinical trials, and new Certificate of Confidentiality rules. There will also be time set aside for Q&A with the expert panel of ACRP Regulatory Affairs Committee Members.

Learning Objectives:

Recognize selected advantages and procedural differences when conducting clinical trials in Latin America
Understand when a “Certificate of Confidentiality" is appropriate for your trial, what it covers, and how one is obtained
Keep up-to-date with recent key changes to US regulations affecting clinical trials conduct and monitoring

Anne Blanchard CCRA

CEO - Development Strategy and Quality Assurance, Blanchad & Asociados - LATINABA

Appearances