Call for Papers
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 in social media, scrutiny of educational material under "safe harbor" and apparent conflicts of interest at a public event create a sink hole 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 should you Attend
Limitations on commercial free speech
Avenues of off-label information
Working in a "safe harbor" for off-label information distribution
Social media and your regulatory responsibilities
Correcting off-label information
Factoring in cognitive psychology
Areas Covered in the Session
Learn to navigate through FDA requirements
Understand that your right to free speech is limited
How to get around FDA prohibitions
Ways to manage your presence in social media
How to identify an off-label problem and corrective action
Under how FDA applies cognitive psychology principles
Who Will Benefit
Quality Systems Auditors
In-house Legal Counsel
Customer Support Staff
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.
Credits and Sources
| Social Media Promotion 2019 : 3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion|