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Free Pharmacovigilance Webinar: Just two days left to register!

Published on 07/11/16 at 11:25am

There are only two more days to register for our free pharmacovigilance webinar on 10 November, in association with PrimeVigilance. You can register for the event here.

Throughout the webinar, PrimeVigilance Medical Director Dr. Cvijeta Bielen will be providing 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 will be discussing 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 this webinar will be 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 will cover the potential use of EV data to detect and analyse unapproved use the reaction/event and sender’s diagnosis fields. Areas to be considered include: 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 will also be available to answer any questions you may have, offering you the benefit of her knowledge and experience.

Click here to book your place today. If you require further information, please do not hesitate to contact us.

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