Greg Ball, of ASAP Process Consulting and Mary Nielson of Eli Lilly present:  Reimagining a Safety Submission – Aggregate Safety Assessment Planning.  The focus of this Community Forum was the various efforts related to interactive safety reviews. The presentation was followed by a discussion on the end goal, potential impact on submissions, and different models...

The PHUSE Safety Analytics Working Group welcomes Greg Ball, ASAP Process Consulting, Jacqueline Corrigan-Curay, FDA, Barbara Hendrickson, University of Chicago & Brian Waterhouse, Merck to discuss Scientific Evaluation of Safety Data and Aggregate Safety Assessment Planning for IND Safety Reporting, part 1 of a 5 part Webinar Series.

Greg Ball PhD Chairs this session at the DIA Annual Meeting to explore three real-world examples of the benefits of artificial intelligence in pharmacovigilance data handling. The examples will include triage of COVID-19 vaccine adverse events, automated analysis of case narratives, and results of work from the TransCelerate initiative.  Greg joins fellow speakers Jane Carroll-...

Greg Ball leads the Roundtable Discussion 'sfor DIA Clinical Safety & Pharmacovigilance Community to follow up the session: Operationalizing FDA Medical Queries.