As the holder of a marketing authorization for a medical product, you are obliged under the Medicines Act (AMG) of the Federal Republic of Germany to record and report to the competent authorities any suspected case of a serious adverse reaction that has come to your knowledge, whether in Germany or abroad.
In order for you to be able to fulfil your legally mandated documentation and reporting obligations without worries, we offer with our software solution evalii, an absolutely reliable and audit-compliant monitoring system. Our automated system extracts reporting-required contents in the form of articles and comments from your social media channels, forums and e‑mails and classifies them according to your PV-relevance by means of a specially developed algorithm. We do not only work locally, but also with European and US-American legislation.
- evalii scans incoming contributions and comments around the clock and documents them within seconds.
- Our fully automaticated algorithm classifies new messages according to your PV relevance.
- a PV Manager checks all incoming messages and forwards them to you if necessary or reacts according to your specifications.
If you have any further questions, please feel free to contact us at any time.