This webinar was hosted by SPEAC and held via Zoom on April 24, 2023. The webinar consisted of an introduction by SPEAC Scientific Coordinator, Dr. Miriam Sturkenboom, and a 45-minute presentation on the use of AESI background rates for observed versus expected analysis. The webinar concluded with a Q&A session. SPEAC invited speakers from different regulatory agencies (US FDA, CDC, and EMA) who provided their perspectives on how these analyses are conducted and used in different organizations. The speakers confirmed the relevance of background rates of AESI and their use to rapidly assess signals against continuous reports. SPEAC’s AESI lists provided a good basis for generating background rates.
The SPEAC Executive Board, Meta-DSMB, and Project Management Team joined CEPI’s Clinical Development Team in London in June to d...
