PrimeVigilance is pleased to announce that Dr Cvijeta Bielen, Medical Director, will be running our next webinar on the key topic: EVDAS outputs are available to MAHs – what now?
During the webinar, Dr. Bielen will provide practical advice on:
- How to plan signalling frequency;
- What sources of data need to be considered;
- What best to focus on during signal detection vs. signal evaluation reviews; and
- The robust documentation of activities.
This webinar will focus on giving the listeners a comprehensive overview of all the new regulatory requirements for products on an additional monitoring list, and some last-minute additional requirements for other products that were not expected to be impacted by EVDAS during 2018.
The webinar will be followed by a Q&A session where you will be able to ask questions and receive direct feedback on key areas of uncertainty.