Exploring the FDA’s Patient-Focused Drug Development Guidance Series to Ensure More Consistent & Systematic Measuring of Patient Engagement

Time: 10:35 am
day: Pre-Conference Workshop Day


This workshop will discuss:

  • What the new FDA guidance document is, why it is needed and how it will be implemented
  • Exploring how to navigate initial discussions with the FDA to ensure alignment on data collection methods that meet their expectations and criteria for future evaluations
  • Illuminating the challenges of trying to apply this guidance tactically
  • Highlighting the expected knock-on consequences for other global markets