Medmarc

Webinar Details

Ripped from the Headlines: Medmarc’s Risk Management Team Discusses Lessons Learned from Life Sciences in the News

Previously Recorded on October 23, 2017

In a time of rapid scientific and technological development, and with the tidal wave of change brought by a new administration, life sciences topics are frequently in the news. In this webinar, the attorneys in Medmarc’s risk management department will take you through a few of the year’s most cogent news items and distill the key points life sciences companies need to know.  

In this webinar, you will hear: 

  • Why shortcuts in the clinical research process may be bad for business
  • What FDA’s latest guidance on cybersecurity means and how life sciences companies are faring on product security
  • The latest on FDA’s regulatory pilot programs and the agency's changing vision for the future

Sara E. Dyson, Esq. is the Assistant Vice President of Risk Management for the Medmarc Insurance Group.  Ms. Dyson consults with life sciences companies to develop products liability risk management strategies and assist with related specialty areas, such as FDA compliance, post-market surveillance, product safety, and recalls.  She regularly performs evaluations of life sciences products and manufacturing operations to identify products liability risks and offer solutions to control potential losses and costs. 

Additionally, Ms. Dyson is the author of numerous articles on products liability risk management that have appeared in industry media outlets.  In 2012, she was invited to join the Health Sciences Council for Underwriter’s Laboratory (UL), a global independent safety organization that develops safety standards and certification programs for a variety of products.  Ms. Dyson advises UL on safety trends for medical devices.

Ms. Dyson received her law degree from the University of Wisconsin Law School and is a member of the Wisconsin and Virginia Bar Associations.  She is also a graduate of the University of Michigan. 

Courtney S. Young, Esq., is the Senior Attorney for Risk Management for the Medmarc Insurance Group.  Her primary responsibilities include the development of resources on products liability avoidance and regular correspondence with brokers, policyholders, and underwriters in 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.

Ms. Young received her law degree from the George Mason University School of Law and is a member of the California and District of Columbia Bars.  She is also a graduate of the University of California, Santa Barbara, where she received a BA degree.

Kathryn Tarallo Klaus, Esq., is a Risk Management Attorney for the Medmarc Insurance Group. 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. She now brings this experience in navigating the FDA landscape to Medmarc, where she works with colleagues in-house, as well as with policyholders, in developing and strengthening 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.

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