As life science companies strive to comply with adverse event reporting requirements, regulatory professionals should understand the product liability implications of doing so. Compliance with FDA regulations will not insulate your Company from product liability claims. In order to navigate the regulatory framework and challenges it creates with a focus on litigation mitigation and prevention, the regulatory practitioner should have a sound understanding of how adverse event reports are affirmatively used by plaintiffs’ attorneys.

This presentation showcases a series of on-going litigations and recent court decisions which highlight the use of adverse event reports, efforts to establish them as evidence of causation and the impact of foreign regulatory decisions. It also addresses the importance of developing specific business practices to thwart these efforts.

This audio conference covers:

• How plaintiffs attempt to make use of ADE reports
• Assessing whether they are evidence of causation in products liability litigation
• Understanding the potential factors behind the number of reports for a particular product; response to underreporting
• Evaluating and acting upon specific adverse events
• Determining when to make label changes
• Reporting to regulatory agencies
• Safety signal programs and follow-up
• Impact of foreign regulatory responses to AE reports
• Reconciling foreign and US regulatory activity
• Social media and reporting of AEs
• Adverse event monitoring as a tool for risk management

About the speaker:

Caryn Silverman, a partner in Sedgwick’s New York office, concentrates her practice on product liability, with a specialty in drug and medical device litigation. She has served as national and local counsel in pharmaceutical mass tort litigation, and is a prolific author and frequent speaker on legal issues pertaining to FDA-regulated products. Ms. Silverman is Chair of the New York State Bar Association's Food, Drug & Cosmetic Law Section. She is admitted to practice in New York and New Jersey and before the U.S. District Courts for the Southern and Eastern Districts of New York and the District of New Jersey. She holds a B.S. from Cornell University and J.D. from Benjamin N. Cardozo School of Law, Yeshiva University.

Who should attend?

• Regulatory Affairs
• Sales & Business Development
• Marketing Directors/Managers
• Legal Counsel