Hot Topics in Life Sciences: What does this mean for products liability?
In this installment of Medmarc’s webinar series, Kate Klaus and Zuhal Reed, our attorneys from Medmarc’s Risk Management Department will guide a discussion on some of the top life sciences news stories of the past year and their potential implications for products liability.
Topics will include:
- The continued impact of COVID19 on the life sciences industry;
- Medical Device trends from 2022; and
- The Biden Administration’s FDA - challenges and achievements in 2022
Kathryn Tarallo Klaus, ESQ. | Sr. Attorney Risk Management / FDA Specialist | Medmarc
Kathryn (Kate) Tarallo Klaus, Esq., is a Risk Management Attorney with Medmarc. Her focus is on legal matters faced by participants in the life sciences industry, specifically FDA regulatory compliance. She began her career with FDA’s Center for Biologics Evaluation and Research, where she worked on the Broad Spectrum Autism litigation under the National Childhood Vaccine Injury Act. After leaving FDA, she worked in private practice with two national law firms, counseling clients through all phases of the regulated product life cycle, including development and approval, manufacturing, labeling and advertising, and post-market concerns and enforcement.
Ms. Klaus advises clients regarding defense against regulatory enforcement actions, including FDA 483 Inspectional Observations, Warning Letters, U.S. Customs detentions, product recalls, and DHHS OIG exclusion proceedings. She has also counseled clients through all health law-related aspects of major transactions, from conducting facility and records compliance auditing during due diligence investigations, to federal and state licensure requirements, and the development and implementation of improved compliance programs post-closing. She brings this experience in navigating the FDA landscape to Medmarc, where she works with colleagues in-house, as well as with policyholders, in developing regulatory compliance strategies in an effort to mitigate products liability losses.
Ms. Klaus is a graduate of The Catholic University of America, Columbus School of Law, and the College of the Holy Cross.
Zuhal Reed, ESQ. | Sr. Staff Attorney, Life Sciences Risk Management | Medmarc
Zuhal Reed joined the Risk Management team in March 2021. Ms, Reed came to us from Shaub, Ahmuty, Citrin, and Spratt, LLP, a healthcare-centric law firm located in New York City, where she worked on healthcare professional liability litigation. Prior to that Zuhal interned with Intermountain Healthcare, where she advised the hospital system on compliance and risk management matters. Zuhal resides in Washington, DC.
Ms. Reed is a graduate of the University of Utah S.J. Quinney College of Law, Salt Lake City, and the University of Toronto, Ontario Canada with an Honors BS in Human Biology and Honors BA in English Literature.
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Hot Topics in Life Sciences: What Does This Mean For Life Sciences Products Liability?