Eudravigilance setup and maintenance
Dedicated team specializing in establishing and maintaining Eudravigilance systems, ensuring efficient and compliant collection, management, and reporting of adverse drug reactions. We prioritize transparency and adherence to regulatory requirements.
Expert team supporting the marketing authorization holder (MAH) and their QPPVs in data collection, submission, and management of Eudravigilance systems.
- Electronic reporting of SUSARs (clinical trials), and ICSRs (post
- Download and review of ICSRs for MAH products
Updates related to SmPC, changes to the name and contact details of the QPPV, changes in the location of the PSMF, transfer of marketing authorization etc. through the article 57 maintenance submission process.
EudraVigilance data analysis system (EVDAS) Support
- Electronic reaction monitoring reports (eRMRs)
- Line listings of individual cases of suspected adverse reactions
- Individual case report forms