What are the regulatory tasks in the oversight of clinical trials?
PAHO invites you to this seminar on the oversight of clinical trials with drugs and medical devices and the regulatory and ethical aspects that are often not correctly differentiated. Therefore, the role of regulatory authorities and research ethics committees (RECs) are confused.
This seminar is co-organized by PAHO's Regional Program on Bioethics (Department of Evidence and Intelligence for Action in Health) and Quality and Regulation of Medicines and Health Technologies Unit (Department of Innovation, Access to Medicines and Health Technologies)
- To explain clinical trials' oversight processes
- To define the strictly regulatory tasks
- To differentiate the responsibilities of national regulatory authorities and RECs
- To discuss the challenges entailed by the oversight of clinical trials