On the last lunch and learn of this series, speakers discuss the most important aspects of practicing in the medical device and digital health space and what makes each industry unique. Panelists will answer key questions about the industries such as: What makes FDA regulation of medical devices and digital health different from other industries? What challenges are impacting the medical device and digital health industry? How do medical devices and digital health law overlap? Panelists will further explain how you can enter these practice areas and discuss innovative topics
Speakers
Laura Bailis, Senior Counsel, Regulatory Law, Johnson & Johnson
Justine Lei, Associate, Sheppard Mullin
Moderated by Andrea Chamblee, Adjunct Assistant Professor, George Washington University
LAURA BAILIS is Senior Counsel, Regulatory Law at Johnson & Johnson. Laura’s practice focuses primarily on J&J MedTech’s digital medical devices and software. Prior to J&J, Laura worked as Senior Counsel, Regulatory and Product at Fitbit, and, subsequent to Google’s acquisition of Fitbit, as Associate Corporate Counsel at Google. In these roles, Laura supported Fitbit’s software as a medical device programs, consumer health products and services, research studies, and clinical trials. Prior to her in-house roles, Laura served as an Associate Chief Counsel in the Office of the Chief Counsel at FDA as a member of the medical device counseling team, where she advised the Center for Devices and Radiological Health on a variety of issues across the medical device life cycle. Laura is a graduate of Washington University in St. Louis and has a JD and MPP from the University of Chicago. Laura is based in the Bay Area.
ANDREA CHAMBLEE is a Fellow at the Regulatory Affairs Professional Society (RAPS) and at Everytown for Gun Safety. She is a dedicated FDA professional with 30+ years’ experience in regulatory affairs and compliance and a wealth of institutional knowledge and a record of solving difficult leadership, policy, performance, and educational challenges. Andrea has been an associate adjunct professor and author of the complete course materials, Introduction to Regulatory Affairs: An Outline and Overview, updated annually 2008 to 2019 for Master’s Level programs in FDA Regulatory Affairs since 2001. She has written other educational materials for RAPS and FDLI. Andrea prepares for, manages, and responds to FDA inspections and regulatory actions. She successfully propels products and solutions for all regulated products: to assess, identify, collaborate, and implement compliant solutions in resource-limited environments to secure and expand approvals while improving productivity, as an experienced team leader and motivator, a coach, and mentor. Andrea was inducted into the first class of Regulatory Fellows and is the founder of the DC Metro Area Chapter, and Leader of RAPS. She has been a frequent speaker, chapter co-chair; and editor of Regulatory Affairs Focus magazine. Andrea is a co-author of The Capital of Basketball by John McNamara selected by the New York Times Holiday Books for 2019; ISBN-10: 1626167206. She is a co-producer of the DC-area Emmy nominated short, Survived by WUSA, 2019.
JUSTINE LEI is an associate in the Corporate and Governmental Practice Groups in the firm’s New York office and is a member of the firm’s healthcare industry team. Justine represents clients in the healthcare industry on a range of transactional, regulatory and business matters. She advises clients in connection with corporate transactions, including mergers and acquisitions, corporate restructuring and governance matters as well as a range of regulatory issues such as corporate practice of medicine compliance, change of ownership, physician contracting, Stark Law and Anti-Kickback Statute (AKS) compliance. Justine also advises clients on various data privacy and healthcare technology matters, including telemedicine and data security. Justine received her BA in Philosophy and Psychology from New York University and her JD from Fordham University School of Law, where she was a Notes and Articles Editor for the International Law Journal, a member of Moot Court, a board member of the Health Law Society, and served as the President of the Fordham Law Asian Pacific American Law Student Association. During her time in law school, Justine was a judicial intern for the Honorable Denny Chin, Circuit Judge for the United States Court of Appeals for the Second Circuit.November 15, 2022
12:00–1:00 PM ET
Registration
This program is limited to FDLI members who are a part of the New to Food and Drug Law (NFDL), and student members. Registration expires on November 14.
APPLY FOR THE GROUP AND REGISTER FOR THE EVENT
New to Food and Drug Law Group
The New to Food and Drug Law Group (NFDL) offers young professionals with up to six years of experience an opportunity to connect, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Bianca Cardona.
Click here to visit the Lunch and Learn Series homepage.
