Adverse Event Database Searches & IMDRF AE Codes: Digitalized search, evaluation, documentation and integration
Searches in adverse event databases provided by competent authorities are standard post-market surveillance activities that all medical device manufacturers must perform. Typically, results of searches in different databases are documented in Excel sheets and later copied into Word files, e.g. the Clinical Evaluation Report, PMCF Evaluation Report or PMS Report/Periodic Safety Update Report (PSUR). The pitfall of this approach: The media break results in manual work (without creation of any value) and creates the potential for inconsistencies. Furthermore, a proper version control of Excel files is tricky.
In this webinar, we will present you our new Polarion solution avaADVERSE, which was developed for a digitalized procedure for searches in adverse event databases and an automated interface to the FDA databases MAUDE and Recall. We will also show you how results from other databases can be easily imported into Polarion for further processing. The solution includes regulatory-compliant best practice templates for documentation of the search, evaluation of results and integration into clinical evaluation/PMCF and PMS. Additionally, we will explain the application of IMDRF adverse event codes in Polarion.
