VM4: Living with post-authorisation obligations – progress, challenges and future opportunities


The first speaker, Kathrin Schirmann, gave an overview of the responsibilities of MAHs and authorities for PhV safety data and signal detection, and presented some of the options in the EudraVigilance (EV) Vet data warehouse. The Pilot Signal Management Expert Group group aims to develop and test options in the signal management process. However, the work is still in the pilot phase. She emphasised that the authorities do not want to duplicate the effort already made by MAHs and that individual case review was still at the core of decision making after signal assessment. When a signal is confirmed, the regulatory action, eg., change of summary of product characteristics (SPC) text, must be submitted by the MAH as a variation requiring assessment (VRA) and also be submitted to the IRIS system. Some upcoming system developments are the sales data dashboard, where incidence calculation of adverse reactions and their publication can be handled, and trend analyses can be performed. This is expected for end of January 2024.

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