FDA steadily expands the scope and restrictions for the promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume you're 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 by what people are saying about your product. Does FDA hold you accountable?
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 by what people are saying about your product. Does FDA hold you accountable?
Why you should 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
Speaker
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.Who Should Attend
- Regulatory Directors
- Marketing Directors
- Quality Systems Auditors
- Recall Managers
- In-house Legal Counsel
- Customer Support Staff
- Sales Staff
