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.

In this part 3 of PHUSE's 5 part webinar series on Interdisciplinary Safety Evaluation for Learning and Decision-Making, Greg Ball of ASAP Process Consulting joins Mac Gordon, Director of Statistics, Johnson & Johnson, Peg Fletcher, Safety Physician and CEO of MedAssessment, and Scott Proestel, Sr. Medical Officer, FDA to discuss FDA Medical Queries and AE Groupings for...

Jeremy Wildfire, Sr. Director of Biostatistics, Gilead, Steve Mallett, Sr. Manager of Statistics, Veramed & Mat Soukup,  Deputy Division Director and Office Biostatistics representative, FDA/CDER join Greg Ball, ASAP Process Consulting, to discuss interactive safety graphics:  industry's exploration and nascent use, value comparison to traditional static graphics, and exploration of use of interactive safety graphics in submissions...

Greg Ball, PhD, presents to the Society of Decision Professionals webinar series on: Decision Framework for Assessing Safety in Clinical Development Programs

Greg joins Linda Jeng, MD, Associate Director for Biomedical Informatics, FDA, Robert (Mac) Gordon, Sr. Statistician, J&N and Peg Fletcher, MD, Safety Physician and President of MedAssessment, Inc. for a panel discussion on how to operationalize FDA Medical Queries (FMQs) a the World Drug Safety Congress Americas meeting, 2023.

Part 5 and final presentation in the Safety Analytics Working Group webinar series, Interdisciplinary Safety Evaluation for Learning and Decision Making, a collaboration of industry leaders and PHUSE, ASA Biopharm, and DIA, Greg provides a succinct summary of the webinar series directed at busy executives.  Greg is joined by Jacqueline Corrigan-Curay, Director, Office of Medical...

Lecture to the Clinical Research Management Network Webinar-Interdisciplinary Safety Evaluation for Learning and Decision Making, Greg Ball, PhD, ASAP Process Consulting.

Greg Ball represented PHUSE's Safety Analytics Working Group at the PHUSE/FDA Computational Science Symposium (CSS) 2024, along with Scott Proestel, Sr. Medical Officer, FDA, and Mary Nilsson, Statistician, Eli Lilly.  CSS brought together a community of 212 passionate individuals. who gained access to direct insights into regulatory topics from health authorities and explored a range...

A number of questions remain about Safety Surveillance Plans (SSPs). This session, Chaired by Greg Ball of ASAP Process Consulting, presents experiences from  multiple sponsors who have developed processes to address the FDA’s recommendations in the 2021 guidance.  Topics such as:  identifying when a safety surveillance plan (SSP) is warranted; specifics on implementation of the...