Overview:
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction.
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 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
Who Will Benefit:
- Regulatory Directors
- Marketing Directors
- Quality Systems Auditors
- Recall Managers
- In-house Legal Counsel
- Customer Support Staff
- Sales Staff