Overview
Considering the wide range of available tobacco and nicotine products, effective regulation requires substantial research on both product usage and health impacts, as well as understanding of the outcomes and validity of that research. This webinar will cover the basics of academic research, including study design, data gathering, and data analysis, along with the role of research in FDA application review and public health messaging.
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Speakers
Priscilla Callahan-Lyon, Senior Science Advisor, Office of the Center Director, CTP, FDA
Saul Shiffman, Senior Scientific Advisor, Behavioral Science, Study Design, and Analysis, Pinney Associates and Professor, Psychology, Department of Psychology, University of Pittsburgh
Moderated by K. Michael Cummings, Professor, Medical University of South Carolina
SAUL SHIFFMAN is a research professor of psychology (clinical and health psychology), psychiatry, pharmaceutical sciences, and clinical translational science at the University of Pittsburgh. He also serves as Senior Scientific Advisor at Pinney Associates, which consults to JUUL labs, and had consulted Reynolds American and British American Tobacco on tobacco harm reduction. Dr. Shiffman has been conducting behavioral research on nicotine and tobacco for 45 years and has published over 400 scientific papers on topics including smoking patterns, nicotine dependence, smoking cessation and relapse, smoking cessation treatment, and issues in tobacco harm reduction. He has received awards for his research, including an award “for breakthroughs in clinical research,” awarded by the Society for Research on Nicotine and Tobacco and an award “for exemplary work in translating or extending behavioral medicine from research into practical application,” from the Society for Behavioral Medicine.
PRISCILLA CALLAHAN-LYON is Deputy Directory of the Division of Individual Health Science in the Center for Tobacco Products’(CTP’s) Office of Science at the Food and Drug Administration (FDA). Dr. Callahan is a board-certified internist and pulmonologist. After 20 years of private medical practice, Dr. Callahan joined FDA in 2008 as a medical reviewer in the over-the-counter division of Center for Drug Evaluationand Research where she worked extensively on nicotine replacement therapies, and she moved to CTP in 2012. Dr. Callahan is a member of several FDA cross-center groups that are involved with nicotine policy and regulation. She also served as the technical project lead for FDA’s review of the IQOSPremarket Tobacco Product ApplicationsVirtual Learning FAQ
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Summer Learning Series
The Summer Learning Series brings the top thinkers and leaders of our industry to speak on a broad array of topics essential to the food and drug law professional, covering matters that perhaps we all wish we knew a bit more about as we work and converse with clients, colleagues, and the FDA. Join us this June through July and build foundation in the following subjects:
- The Essentials of Clinical Trial Science – Wednesday, June 16
- The Essentials of Statistics for Medical Products Lawyers – Wednesday, June 30
- The Essentials of Tobacco and Nicotine Product Research – Wednesday, July 14
- The Essentials of Machine Learning for Regulatory Attorneys and English Majors – Thursday, July 15
- The Essentials of Food Science – Wednesday, July 21
