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Free Pharmacovigilance Webinar: Available to view now!

Published on 14/11/16 at 10:34am

Pharmafocus, alongside PrimeVigilance, hosted a webinar on 10 November and is now available to view for free.

Throughout the webinar, PrimeVigilance Medical Director Dr. Cvijeta Bielen provided an overview of how E2B (R3) and the planned access to the data in the Eudravigilance (EV) system will affect signal detection. In addition she discussed the potential use of EV data to detect and analyse unapproved use

All marketing authorisation holders are required to continuously monitor product safety, and communicate the findings to all stakeholders concerned with product use. The key deliverable of this continuous monitoring is accurate and user-friendly product information (label). The main tool that enables monitoring is robust signal detection and prompt assessment of new signals.

The aim of the webinar was to view the E2B (R3) fields and aggregate outputs (which will be available to the MAH from EV), from the perspective of regulatory requirements for product label maintenance. Signal detection always starts with the review/analysis of the reported reaction/event and sender’s diagnosis fields. Other E2B fields most relevant for qualitative signal detection are those which:

  • Clarify the temporal relationship between product use and adverse event occurrence
  • Present (lack of) confounding factors
  • Present the risk factors
  • Present the mitigating factors

In addition, this webinar covered the potential use of EV data to detect and analyse unapproved use the reaction/event and sender’s diagnosis fields. Areas that were considered included: relevant MedDRA terminology; other E2B fields; and the use of new validation rules in the safety databases for EEA products to highlight potential reports of unapproved use, taking XEVMPD as reference.

Dr. Bielen provided answers to questions posed to her by listeners, which can be heard at the end of the recording.

Click here to find the latest webinar.

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