The Drug Safety Research Unit (DSRU) is a leading independent academic research organisation internationally renowned for its work in Prescription Event Monitoring (PEM), Drug Safety and Educational Activities for more than two decades.
In partnership with GPs in England we aim to protect patients from unwanted adverse effects of newly marketed medicines by way of our unique method of monitoring patients during the early life of a new medicine.
Through our research activities, we offer advice and support for risk management plans, as well as providing data to regulatory authorities in support of their public health role.
The DSRU is the operational arm of the Drug Safety Research Trust, a registered independent medical charity No. 327206 governed by a Board of Trustees and is an Associated Department of the School of Pharmacy and Biomedical Sciences, University of Portsmouth.
Postgraduate Certificate, Diploma and Masters in association with the University of Portsmouth.
The meeting that updates the experts and educates the beginner
This course covers the evolution of the Periodic Safety Update Report (PSUR) into the new PBRER (Periodic Benefit-Risk Evaluation Report) format. Participants will gain an understanding of the revised ICH E2C Guideline (R2) and the new EU legislation for writing PSURs, including the format and content of these reports. This course is essential for those who have no previous training in writing PSURs or PBRERs as well as those who have a basic knowledge which they wish to improve, and for those who are familiar with the old PSURs, but who now need to learn more about the challenges of the new PBRERs.