Standardizing Patient Engagement Metrics for Regulatory Submissions
Time: 1:02 pm
day: Pre-Conf Day
Details:
- Understanding the FDA’s requirements for patient experience data in NDAs
- Defining key metrics that satisfy both regulatory and commercial needs
- Demonstrating the financial and clinical ROI of patient engagement activities
- Exploring case studies on how pharma companies are securing regulatory approvals with patient data
Discussing questions such as:
- How can we measure PE to add value to regulatory submissions, what should we be measuring, are we measuring the wrong things, how do we innovate the way we are quantify the input from patient community in a way that regulatory bodies will accept, and are there any roles that have been put out about engaging with patient advocacy stakeholders?
