概要
This practical training course will help industry professionals to keep up with the new demands. It introduces essential aspects of medical writing of aggregate safety reports (PSURs and PBRERs) in the context of 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) (plus Q&A) guideline on the PBRER, EU Good Pharmacovigilance Practices (GVP) - Module VII, as well as global acceptability and local variability in the requirements.
Course will demonstrate best practices in source data collection, about the essential role of quality checks (QC) during the whole process of report preparation, and about critical aspects of medical writing, including data editing and presentation.
A practical exercise involving key aspects of the medical writing process, based on real-life examples, will be included.
Participants will be provided with preparatory material to allow for maximum benefit from the team exercises onsite.