Overview
Up to date medical writing skills are key to keep up with the changing regularities in compliance reporting. In The Medical Writing of Periodic Safety Update Reports (PSUR/PBRER) Training course, you learn how to master the increasing complexity of the documents. This virtual live training will help you to gain a deeper understanding of best practices in source data collection, essential role of quality checks (QC) during the whole process of report preparation, and critical aspects of medical writing, including data editing and presentation. Gain confidence in writing aggregate safety reports (PSURs and PBRERs) in the context of the current legal framework in the EU and globally.
Course participants will learn all they need to know about the requirements set out in the ICH E2C(R2) guideline on the PBRER, EU Good Pharmacovigilance Practices (GVP) – Module VII – with a global perspective and local characteristics (plus Q&A).
Hands-on Learning
In this workshop, practical exercises will train you in the medical writing process, based on real-life cases. Our experienced instructors take you through the latest requirements of the current legal framework. Participants will complete two knowledge checks. The first will take part before the practical exercise, focused on drafting the key parts of PSUR in groups. In a second check, you will complete an online test of the learned knowledge.
What participants from previous course say:
"This was an amazing session organized by DIA. Really helped a lot in better understanding of various aspects regarding PSURs. Special thanks to faculty for those extra efforts and taking special care of all the participants."
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