It is more important than ever to connect and share ideas. The Law Over Lunch series offers FDLI members the exclusive opportunity to engage in facilitated virtual discussions over lunch on topics of interest to the food and drug law community. This event features unique and co-occurring discussion groups, limited to ten attendees to encourage fruitful conversation. This member-only benefit is a chance to closely learn from, educate, and network with other professionals in the field on new and pertinent topics.
Please only sign up for one discussion as they will take place at the same time.
Table Topics and Facilitators
Clinical Decision-Support Software: Assessing the Impact of FDA’s New Guidance
Bradley Merrill Thompson, Partner
Epstein Becker & Green, PC
Status Report on FDA’s Regulation of Cannabis Products
Madeleine Giaquinto, Director of Regulatory Affairs,
Greenleaf Health, Inc.
Does FDA Have Sufficient Product Information and Scientific Expertise to Make PMTA Decisions?
Jim Solyst, Principal
JMS Scientific Engagement
BRADLEY MERRILL THOMPSON is a shareholder in the law firm of Epstein Becker & Green, PC, in the firm’s Washington D.C. office. Thompson counsels software, medical device, and drug companies on a wide range of U.S. Food and Drug Administration (FDA) regulatory issues and leads the firm’s artificial intelligence (AI) practice. Thompson also serves as Chairman of the Board and Chief Data Scientist of Eckstein Becker Green (EBG) Advisors, Inc. Affiliated with the law firm, EBG Advisors is a consultancy that takes a multidisciplinary approach to helping health care and life sciences companies navigate the regulatory obstacles they face. For trade associations, Thompson has served as counsel to the Continua Health Alliance, and as General Counsel to the Combination Products Coalition, mHealth Regulatory Coalition, the Clinical Decision Support Coalition, and AI Startups in Health Coalition. He has taught Food & Drug Law at Indiana University School of Law and has served as Co-Chair of the Food & Drug Law Committee of the American Bar Association and the Medical Device Committee of the Food and Drug Law Institute (FDLI). He received his BA and MBA from the University of Illinois at Urbana-Champaign and his JD from the University of Michigan Law School. In 2022, Thompson graduated with a Master of Applied Data Science from the University of Michigan.
MADELEINE GIAQUINTO is manager of regulatory affairs at Greenleaf Health, Inc. She provides clients with timely analysis of FDA regulations, policies, and guidance documents related to good practice standards for FDA-regulated products, including drugs, biologics, medical devices, CBD, and tobacco. In addition, she advises clients on strategic engagement with FDA regarding a range of compliance-focused issues, such as remediating deficiencies identified in FDA Form 483 observations and FDA warning letters, as well as building mature quality management systems at manufacturing facilities within FDA’s purview. Madeleine has worked in diverse settings across the life science landscape, including legal, government affairs, and public health policy practices. She has a BS in biology from Georgetown University and a JD from George Mason University School of Law.
JIM SOLYST is Principal with JMS Scientific Engagement. He previously worked for Swedish Match where he contributed to the preparation of the General Snus PMTA and MRTP. He is a frequent contributor to FDLI journals and speaker at FDLI conferences.November 17, 2022
12:00-1:00 PM ET
Registration is open to FDLI members only and is first come, first served.
This is a complimentary virtual event.
Please only sign up for one discussion as they will take place at the same time.
For questions, please contact Tess Garraty.
