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Overview:
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Trolling for off-label information on social media, scrutiny of educational material under "safe harbor" and apparent conflicts of interest at a public event create a sinkhole for firms even though it may seem innocent in your eyes.
Facebook, Twitter or chat rooms can be rampant with off-label information. You even may be surprised about what people are saying about your product. Does FDA hold you accountable?
Why you should Attend:
Areas Covered in the Session:
Who Will Benefit:
Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health.
He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed.
Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD - Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology - Boston University with internship through Harvard University.