The life sciences landscape is constantly—and rapidly—evolving. Staying on top of news and trends is a challenge in such a dynamic environment. In this webinar, Medmarc’s Risk Management attorneys, Courtney Young and Kate Klaus, will break down some of the most recent top stories relevant to the life sciences industry.
You will learn about:
Kathryn Klaus, Esq. is a Risk Management Attorney, FDA Specialist. 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, Ms. Klaus 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. She has advised 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 now brings this experience in navigating the FDA landscape to Medmarc, where she works with colleagues in house, as well as with policy holders, 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. She is a member of the Massachusetts Bar.
Courtney Young, Esq. is Senior Attorney for Risk Management. Her primary responsibilities include assisting brokers, policyholders, and underwriters with efforts to evaluate and mitigate products liability risk. Ms. Young publishes articles on products liability risk management for industry organizations, such as IMDA, and publications, such as Life Sciences Panorama. She also maintains a blog on products liability issues for the life sciences industry, on which she discusses recent products liability litigation, FDA regulatory activity, and industry news.
Prior to joining Medmarc, Ms. Young concentrated on contract law in private practice, and spent time at the U.S. Small Business Administration, giving her unique insight into the issues facing Medmarc’s smaller policyholders.
Ms. Young received her law degree from the George Mason University School of Law and dual bachelor degrees in business economics and political science from the University of California at Santa Barbara. She is a member of the California and District of Columbia Bars.