PART 2: EVDAS outputs are available to MAHs – what now?

With EVDAS (EudraVigilance Data Analysis System) outputs now available to Marketing Authorization Holders (MAHs), this follow-up PrimeVigilance webinar provides essential guidance on navigating the responsibilities and workload implications during this pilot period.

This session delves into the current discussions with regulatory inspectorates, focusing on the “grey zones” impacting workload, and offers insights into best practices for signal validation, report storage, and access requests.

This webinar is ideal for pharmacovigilance professionals seeking clarity on handling EVDAS outputs effectively and understanding inspectorate expectations, particularly for generic companies.

Key Takeaways Include:

• Key considerations for signal validations versus further signal assessments
• Guidance on when it is necessary to request L2B access
• Best practices for storing EVDAS reports in safety databases
• Specific expectations for generic companies in handling EVDAS data