Refreshing EMA webinar on signal management
EudraVigilance Veterinary (EVVet3) is one of the systems that supports the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), specifically its provisions on the Union Pharmacovigilance Database. On 27 October 2022, EMA offered a refreshing webinar on signal management overview. This session followed-up previous webinar on signal management and provided an interesting oversight into the system.
Marketing authorisation holders now follow the new requirements coming into force on 28/1/2022 with the Regulation (EC) 2019/6 for signal management in veterinary pharmacovigilance. With the release of EVVET3, the Union pharmacovigilance database for veterinary products, new analytical tools have been made available by EMA for signal analysis. This novelty brings a brand new approach to signal management and conclusion, and a lot of questions on how to implement this process, as the system went live very recently.
EMA focused this 6th session on a refreshing meeting about our understanding on signal management, followed by a demonstration of signal management case scenarios and a demonstration of signal and annual statement submission.
It also provided the opportunity for participants to ask any questions about the pharmacovigilance signal management of veterinary medicinal products in the EU.
Previous training sessions around the new requirements in pharmacovigilance for veterinary products were proposed and published by EMA before the system go live: https://www.ema.europa.eu/en/veterinary-regulatory/post-authorisation/pharmacovigilance/eudravigilance-veterinary#webinars-and-training-activities-section
EMA took the pragmatic approach to record and publish this session on EMA’s YouTube chanel (https://www.youtube.com/user/emainfo/).
For those who could not attend or for review the webinar again, see more information on: https://www.ema.europa.eu/en/events/union-pharmacovigilance-database-refresher-webinar-signal-management-overview#video-recording-section.