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
Details:
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
