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...

Greg Ball, PhD, of ASAP Process Consulting joins Patrick Schnell, Executive Medical Director and Global Product Safety Lead at BeiGene, to present "Continuous safety information of RCT with blinded treatment information" to the quarterly meeting of ASA's Biopharmaceutical Section, on January 21, 2025.  Greg and Patrick are joined from other industry key opinion leaders from...

Taught by Greg Ball PhD, Safety Scientist, and Barbara Hendrickson MD, Safety Physician, this session will describe how the ASAP supports multidisciplinary safety planning, ongoing aggregate safety evaluation, IND safety reporting decisions, and evaluation of product level safety data and the Safety Topics of Interest, which have the potential to influence a product’s benefit: risk...

CITI Program in collaboration with ASAP Process Consulting, Inc. has created a training resource that is free for industry, in the spirit of advocating for FDA's IND Safety Final Rule (2010).  Greg Ball, PhD, presents a detailed introduction to the Aggregate Safety Assessment Planning process and IND Safety Reporting for any industry professional, patient, or...