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.

Chaired by Greg Ball of ASAP Process Consulting and PHUSE AE Groupings in Safety (AEGiS) Project Team, this session introduces new FDA guidance focused on enhancing safety analytics and discuss how cross-industry working groups have been preparing the ecosystem for operationalizing them: FDA Medical Queries and Standard Safety Tables and Figures.  In addition to Robert...

Greg joins Jacqueline Corrigan-Curay, Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, and Robert (Mac) Gordon, Director, Biostatistics, Johnson & Johnosn Innovative Medicines, to present and introduce how the program safety analysis plan (PSAP) allows reviewers an effective way to perform annual aggregate safety review across a compound. Utilizing an interactive...

Greg facilitates this webinar with Y. Veronica Pei, MD, MEd, MPH, FACEP, Lead Physician, Biomedical Informatics and Regulatory Review Science, FDA, Mary Nilsson, Statistician, Eli Lilly, and Jim Buchanan, Covilance, to explore FDA's use of standardized tables and figures.  This webinar series was created and conducted in collaboration with PHUSE, ASA Biopharm and the DIA.