Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management 2012

Key Topics

• What the law of off-label promotion of drugs and devices is
• What drug and device labeling is and is not
• Why drug and device firms favor off-label communications
• How freedom of speech and the First Amendment may be important
• Changes that occurred to off-label communications with the onset of the Internet
• Earlier FDA Guidance regarding off-label communications to learned intermediaries
• What the Guidance covers and what it does not include
• The long awaited FDA Guidance explained
• Using the developed protocol to follow FDA Guidance on off-label claims
• Establishing procedures to have a viable and compliant off-label policy
• The use of risk management in an effective manner to promote off-label claims based upon freedom of speech

Who should Attend

Attendees from drug and device companies, including Labeling, VP, Marketing, IT, Regulatory Affairs, Top management and Product Development.