Agenda

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  • Review of FDA’s withdrawn guidance on help-seeking communications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
 
8:00 AM - 8:30 AM
 
8:30 AM - 9:15 AM
  • Review the substantial evidence standard, what fails to meet that standard, and when other standards apply
9:15 AM - 9:30 AM
 
9:30 AM - 10:15 AM
 
10:15 AM - 10:30 AM
 
10:30 AM - 12:00 PM
  • Review of the three social media guidances released in 2014
  • Post-marketing submissions (2253 filing)
  • Presenting risk information in space-limited contexts
  • Correcting misinformation on third-party sites
  • Latest enforcement lessons
12:00 PM - 1:00 PM
 
1:00 PM - 3:00 PM
  • Apply the lessons from the earlier part of the workshop to specific product promotions. Work in teams to evaluate specific promotional tactics, determine what (if any) parts of the promotion are problematic, and how to provide direction to a brand marketer to make the promotions compliant.
3:00 PM - 3:15 PM
 
3:15 PM - 3:45 PM
  • Overview of the standard promotional review process
  • Essential traits for any effective process
  • Key decisions in establishing or improving performance
  • Effective use of metrics for evaluating performance
3:45 PM - 4:15 PM
  • Key resources to stay on top of the latest ad-promo updates.
4:15 PM