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Acadustri's position as a hugely experienced industry leader in the preparation of safety documents means that we are well placed to both write and provide guidance regarding the increased scientific complexity of PSURs and RMPs since the Good Pharmacovigilance Practices guidelines were implemented in July 2012.
We also have expertise in the preparation of clinical/regulatory documents, articles for publication in peer-reviewed journals, as well as congress and training materials.
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.
Effective preparation of fully compliant pharmacovigilance reports has become even more time consuming after implementation of the Good Pharmacovigilance Practice measures. Acadustri offers a bespoke consulting service to pharmacovigilance departments to ensure compliance, quality, and efficiency, which can be wholly tailored to your company needs.
Contact us to discuss your company needs.