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
Table Topics and Facilitators
Please only sign up for one discussion as they will take place at the same time.
Cannabis Legalization in North America – Emerging Trends and Updates from the North And South
Juan Luis Serrano Leets, Partner, Sánchez Devanny & Teresa Reguly, Partner, Torys LLP
Nicotine Misperceptions and Stakeholder Responsibilities
Elizabeth A. Oestreich, Vice President, Regulatory Compliance, Greenleaf Health, Inc
Emergency Use Authorization: Past, Present, and Future
Bill Schultz, Partner , Zuckerman Spaeder LLP
JUAN LUIS SERRANO LEETS is a partner at Sánchez Devanny where he leads the Intellectual Property and Data Privacy practice groups and is the co-head of the Life Sciences Industry Group. He has broad experience in high level management of complex legal and policy issues in Mexico and Latin America. Juan Luis is Councilor to the Mexican Health Foundation (FUNSALUD), a member of the board of the Association of Pharmaceutical Industry Physicians and Professionals (AMEIFAC) and of the Commission of Legal Affairs of the National Chamber of the Pharmaceutical Industry (CANIFARMA). He is also a professor of Sanitary Law in the Escuela Libre de Derecho. Before joining Sánchez Devanny, Juan Luis was Legal Director of the Mexican Affiliate of a Multinational Pharmaceutical Company, with responsibilities over Mexico and Latin America, and worked in lawfirms specializing in intellectual property.
TERESA REGULY is a partner in the IP and Food and Drug Regulatory group at Torys LLP. Her practice focuses on advising clients that sell regulated products in the food, pharmaceutical, biotechnology and medical device industries. Teresa advises on IP and regulatory issues, in particular, patent and regulatory matters in the chemical, biochemical and pharmaceutical fields. Teresa has been involved in drafting and negotiating distribution, licensing, research, marketing and confidentiality agreements for her clients, and provides guidance in Food and Drugs Act compliance, establishment licensing, product licensing, packaging and labeling, and pricing. She has expertise in advertising and promotion of consumer products, food and health products, as well as mandatory reporting and corrective actions. She also advises clients in a range of industries on privacy issues, cross-border transfer of personal information, and compliance with privacy law obligations.
ELIZABETH (LIZ) OESTREICH is Vice President, Regulatory Compliance at Greenleaf Health Inc., where she brings a diverse background of legal, public policy, and non-profit sector knowledge to her position. In her consultation of drug and medical device clients, she works to remediate compliance issues by reviewing Form 483 and warning letter responses, offering guidance on how to build a culture of quality within a company, and providing tips for communicating global quality improvements to FDA. In addition, she advises clients navigating the regulatory landscape for tobacco products and offers guidance on content and format of applications, interpretation of FDA regulation, communication with the FDA, and analysis of proposed rules. Ms. Oestreich also works with clients in the Cannabidiol space, offering strategic guidance and risk-based strategies as the FDA contemplates how to regulate the product category. Prior to joining Greenleaf Health, she served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, DC. While at FDLI, she gained extensive experience in all FDA-regulated product areas through regularly corresponding with FDA officials, as well as creating and supervising the development of curricula for an array of educational programs. She earned a BS in Political Science from the University of Arizona and a JD from the University of the District of Columbia’s David A. Clarke School of Law.
WILLIAM B. SCHULTZ is a partner at Zuckerman Spaeder, where he provides strategic advice and litigation support to generic drug companies and other clients before the FDA and HHS. Between 2011 and 2016, he was General Counsel of the Department of Health and Human Services. He is a member of the Committee on Science, Law and Technology, National Academy of Sciences, and for 10 years he taught Litigation and Food and Drug Law at Georgetown University Law Center. He was also: Deputy Assistant Attorney General, US Department of Justice in charge of appellate litigation nationwide; Deputy Commissioner for Policy, FDA; and Counsel to the House Subcommittee on Health and the Environment (Rep. Henry A. Waxman, Chairman). He began his legal career clerking for Judge William B. Bryant, US District Court, DC, and litigating at Public Citizen Litigation Group. Mr. Schultz received his undergraduate degree from Yale College and his law degree from the University of Virginia School of Law.March 18, 2021
12:00-1:00 PM
Registration is open to FDLI members only and is first come, first served.
This is a complimentary virtual event.
For questions, please contact Tess Garraty.
