Virtual

Jan 12, 2022 10:00 AM - Jan 12, 2022 1:00 PM

Short Course 2: Aggregate Safety Assessments

Instructors

James  Buchanan, PharmD

James Buchanan, PharmD

President, Covilance LLC, United States

Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and Nuvelo. Dr. Buchanan next served at BioSoteria as the head of the medical and safety consulting group. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group Interactive Safety Graphics taskforce that is developing novel, open-source interactive graphical tools to identify and evaluate safety issues during drug development.

Greg  Ball, PhD

Greg Ball, PhD

Safety Data Scientist, ASAPprocess, United States

Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a 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 with statistical and clinical scientists at several pharmaceutical companies. Greg co-leads the PHUSE Safety Analytics working group; he was instrumental in establishing the ASA Biopharm Safety Monitoring working group; and he helped pioneer the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) working group to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.

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