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Jan 25, 2023 10:00 AM - Jan 25, 2023 2:00 PM

Short Course: Aggregate Safety Assessment Planning

This is a Virtual Pre-Conference Short Course in conjunction with the Global Pharmacovigilance and Risk Management Strategies Conference


Greg  Ball, PhD

Greg Ball, PhD

Safety Data Scientist, ASAPprocess, United States

Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). Greg co-leads, with Mary Nilsson and Scott Proestel, the PHUSE Safety Analytics working group; he established (with Bill Wang) the ASA Biopharm Safety Monitoring working group; and he pioneered the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group.

Barbara  Hendrickson, DrMed, MD

Barbara Hendrickson, DrMed, MD

Clinical Associate, Pediatric Infectious Diseases, University of Chicago, United States

Dr. Barbara Hendrickson is a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is currently on faculty at the University of Chicago. Dr. Hendrickson is a physician with subspecialty training in pediatrics and infectious diseases and has 19 years of pharmaceutical industry experience. Dr. Hendrickson has been involved in multiple new product and additional indication submissions. She also has participated in several clinical trial safety initiatives related to implementation of internal data monitoring committees and IND aggregate safety reporting procedures. In addition, she co-leads the DIA-ASA Aggregate Safety Assessment Planning Working Group.

Susan  Colilla, PhD, MPH

Susan Colilla, PhD, MPH

Epidemiology Leader, Teva Pharmaceuticals, United States

Susan is currently at Teva Pharmaceuticals leading its Epidemiology group which provides RWE for Clinical Development, Medical Affairs and PV groups. In 2022, she established a Benefit-Risk Assessment Planning Process at Teva to be used for products from early development stage to post-marketing. Prior to that she was at CSL Behring where she was the Clinical Epidemiology Team Lead and developed an SOP for Benefit-Risk Assessment throughout the drug lifecycle. She has also worked in Epidemiology & Benefit Risk Evaluation and PV groups at Sanofi for over 3 years in rare disease, immunology and neuroscience. She received a Ph.D. in Epidemiology from Univ of Illinois School of Public Health and an MPH from Emory University.

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