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
Quality Management System Regulation (QMSR) – The Road Ahead
Madison Wheeler, Director of Technical Operations
EMMA International Consulting Group
How Cannabis Regulation Will Change the FDA and Vice Versa
James T. O’Reilly, Volunteer Professor
University of Cincinnati
A Means to an ENDS to Accelerate Regulatory Decision-making
Brian Miller, Assistant Professor of Medicine, Johns Hopkins University and Nonresident Fellow, American Enterprise Institute
&
Brian Yagi, Assistant Professor
Johns Hopkins University
MADISON WHEELER serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA) and is currently pursuing her MS in Quality Management.
JAMES T. O’REILLY of the University of Cincinnati College of Medicine was quoted by the US Supreme Court in March 2000 as “The experts have written…” in an FDA decision. He has been active in FDLI since 1974 and chaired the FDLI Programs Committee. In the American Bar Association he chairs the FDA Committee and formerly was the Section Chair of the ABA Section of Administrative Law & Regulatory Practice. Prior to his public health policy role he served 24 years with Procter & Gamble, retiring as Associate General Counsel for Product Safety. He has authored 56 textbooks and 234 published articles.
BRIAN MILLER is a practicing hospitalist, health policy researcher, and health policy analyst. He serves as an Assistant Professor of Medicine at the Johns Hopkins University School of Medicine and an Assistant Professor (courtesy) at the Johns Hopkins Carey Business School. His research focuses on payment policy, FDA regulatory pathways, and healthcare competition policy. Dr. Miller previously served as a Medical Officer in the Office of New Drugs at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, where he focused on pre- and post-market safety regulation, including the review and approval of valbenazine, a first-in-class breakthrough new molecular entity. He also served as a Senior Policy Fellow for Health IT at the Federal Communications Commission, in addition to serving as a Special Advisor in the Federal Trade Commission’s Office of Policy Planning. At the FTC, he worked on competition policy and served as an in-house physician expert for the Bureau of Competition, assisting in merger review and enforcement in health systems, pharmaceuticals, and retail drug stores, including the FTC’s successful action blocking the $7 billion Advocate – NorthShore merger. Prior to the FTC, Dr. Miller was a Fellow at the Centers for Medicare & Medicaid Innovation, where he co-managed the ACO Investment Model, a $114 million project focused on ACOs in rural areas.August 25, 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.
