| 8:00 AM - 8:30 AM | |
| 8:30 AM - 9:30 AM | - Meet your SEC requirements for disclosing information while not running afoul of FDA pre-approval promotion prohibitions
|
| 9:30 AM - 10:15 AM | |
| 10:15 AM - 11:00 AM | - Understanding the timeline and key dates for communications
- Minimizing the pain, while maximizing the impact of initial promotional communications
|
| 11:00 AM - 11:15 AM | |
| 11:15 AM - 12:00 PM | - A review of all the requirements for product promotion of drugs and medical devices, including product name usage, fair balance, and directions for use
|
| 12:00 PM - 1:00 PM | |
| 1:00 PM - 1:45 PM | |
| 1:45 PM - 2:00 PM | |
| 2:00 PM - 2:45 PM | - Review of FDA’s withdrawn guidance on help-seeking communications
- Keys for using disease awareness communications prior to approval
- Essential information for compliantly continuing efforts after approval
|
| 2:45 PM - 3:00 PM | |
| 3:00 PM - 4:00 PM | - Requirements for print promotion
- DTC television vs. YouTube vs. Streaming videos
- Developing a major statement
|
| 4:00 PM - 4:15 PM | |
| 4:15 PM - 5:00 PM | - Avoiding Off-Label Promotion
- Scientific Exchange Exemption
- Responding to Unsolicited Requests
- Distributing Off-label Reprints
- Latest court cases and other developments in off-label information
|
| 5:00 PM | |