is being presented by Caryn Silverman, Sedgwick, Detert, Partner, with Moran & Arnold LLP and airs on Tuesday, September 28th, 2010. For more details or to register, please visit our site at www.fxconferences.com
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.
