is being presented by Kelly Savage Day, Senior Associate, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, March 31st, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
In this brave new world of Twitter, Facebook, LinkedIn and other social media websites, risk and opportunity may be combined. There is no question that social networking represents the emergence of a tremendous marketing and customer education opportunity, but there are also pitfalls for the FDA-regulated company. What happens if you go too far, say too much? Do you need to be concerned about the use of these networking sites by employees?
This audio conference presentation tackles some of the important issues that social media poses for life science companies – the benefits, risks, and mitigating that risk – and provides insight on how to use social media to positively impact your business, without running afoul of regulators.
Showing posts with label Sedgwick Detert Moran and Arnold LLP. Show all posts
Showing posts with label Sedgwick Detert Moran and Arnold LLP. Show all posts
Tuesday, March 1, 2011
Monday, May 10, 2010
Off-Label Information for Medical Device Companies: Regulation, Dissemination & Enforcement
is being presented by Caryn Silverman, Partner, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, June 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com
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 and other enforcement authorities are serious indeed. In this audio conference, our speaker provides background information and examines the current regulatory status of off-label promotion of 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 medical device companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.
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 and other enforcement authorities are serious indeed. In this audio conference, our speaker provides background information and examines the current regulatory status of off-label promotion of 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 medical device companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.
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