Medical Writing Training Course
PSURs and RMPs have increased in complexity since the implementation of the Good Pharmacovigilance Practice measures in July 2012 triggered fundamental changes to the format and structure of aggregate safety reports in the European Union.
These changes mean that significantly more work is required to prepare each report, in addition to a need for increased participation from non-safety departments, necessitating a new approach to the preparation of aggregate safety reports.
Acadustri offers a two-day pharmacovigilance medical writing training course that focuses on the review and analysis of safety data in the new PSUR (the PBRER) and DSUR, as well as presenting strategies to ensure effective planning for large PSURs. Aimed at anyone who needs to produce these reports, the course also explains and demonstrates processes to allow for consistency between safety documents (in particular, the DSUR, PSUR and RMP).
Please contact us to discuss bespoke training packages to support and develop your in-house team.