Understanding the Connection Between Adverse Events and Product Liability Claims

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.

Post-Marketing Issues for Medical Device Companies

Mismanaged product recalls can prove to be a drain on a business’ resources and reputation, both of which can erode a company’s bottom line for years to come. Timely, effective product recalls, on the other hand, can strengthen an organization’s brand image well into the future. Inefficient medical device reporting also presents a clear and present danger. It can damage your company’s reputation and even threaten your ability to operate. So how should an organization alter the way it does business to guarantee that if post-market problems arise, it is equipped to quickly meet and resolve these issues?

This audio conference, conducted by Caryn M. Silverman, partner at Sedgwick, Detert, Moran and Arnold LLP, provides practical, step-by-step information that will help guide you through these challenging post-marketing processes. She defines and discusses medical device reporting, recall classifications and strategies -- as well as where and when exceptions to the rule apply -- Dear Doctor letters and post-marketing surveillance. This event airs on Wednesday, January 20, 2010, for more details please visit our site at www.fxconferences.com

Off-Label Information: Regulation & Dissemination

Off-label promotion is a perennial hot topic within the life sciences. The rules can appear ambiguous at times, but the consequences of running afoul of FDA are serious indeed. In this audio conference, our speakers provide background information and examine the current regulatory status of off-label promotion of drugs and medical devices. The presentation also looks at the "how-tos" for dissemination of off-label information; the role of sales representatives and medical science liaisons (MSLs), and the practical application of the FDA's January 2009 guidance on reprints.

This session also examines the consequences of off-label promotion, reviews some actual enforcement actions taken against life sciences companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.

Off-Label Information: Regulation & Dissemination is being presented by Caryn Silverman & Soo Kim, Partner & Senior Associate, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, September 3, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com