It is a tortuous path for pharmaceutical, medical device and diagnostics companies to produce industry-sponsored speaker programs that are up to ethical and legal guidelines. In recent CIAs, training and promotional review of slide presentations are no longer enough. Live monitoring is required.
Dan Koerner does a great job summarizing which companies are required under CIA to do field monitoring of physician (HCP) speaker programs and monitoring in his presentation:
- Heather McCollum et al on Limiting Off-Label Exposure in Speaker Programs: The Case for Live Monitoring (polaris-solutions.com)
- Field-Based Monitoring Program for HCPs and Sales Representatives (corporatecomplianceinsights.com)
- From Policy to Behavioral Change: 4 How-Tos from ex-AIG CCO (goodpromotionalpractices.com)
- Unsolicited Off-Label Discussion Permissible in Industry-Sponsorted Speaker Programs (goodpromotionalpractices.com)