Date / Time: Tuesday, November 21st / 12-2 pm (Washington DC Time)
In the oversight of clinical trials of drugs and medical devices, regulatory and ethical aspects are often not correctly differentiated. Therefore, the role of regulatory authorities and research ethics committees (RECs) are confused. This seminar aims at explaining clinical trials oversight processes, defining the tasks that are strictly regulatory, differentiating the responsibilities of national regulatory authorities and RECs, and discussing the challenges entailed by the oversight of clinical trials.
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).