PART 1: EVDAS outputs are available to MAHs – what now?

In the first part of our “EVDAS Outputs for MAHs” series, PrimeVigilance and Pharmafocus present an informative webinar led by Dr. Cvijeta Bielen, Medical Director.

This session provides an essential overview of how MAHs can strategically plan signaling frequency, utilize data sources effectively, and differentiate focus areas between signal detection and evaluation. This session also highlights best practices for documenting activities thoroughly and reviews new regulatory requirements for products on additional monitoring lists, alongside last-minute updates for products unexpectedly impacted by EVDAS during 2018.

Join us for this in-depth session to gain clarity on navigating EVDAS outputs and ensure your team is fully prepared for the evolving regulatory landscape.

Key Takeaways Include:

• Effective planning of signaling frequency to align with regulatory expectations
• Identification of critical data sources for comprehensive signal detection
• Focus areas for signal detection vs. evaluation to streamline reviews
• Detailed guidance on robust documentation of pharmacovigilance activities
• Overview of regulatory requirements for additional monitoring products and last-minute updates impacting other products