Summary
Regulatory requirements for long-term data collection following gene therapy are well known,
however many are still seeking pragmatic solutions to address this significant need. Solutions
must decide how to address the bridge from clinical trial to post approval exposures. Adoption of
real-world methods and real-world data can ease this data collection burden. In this webinar,
experts will review some of the ways real world data and methods can support this surveillance
requirement, focusing on pragmatic solutions and adaptive operational approaches.
Webinar attendees will:
- Review regulatory requirements and challenges for long-term follow-up
- Hear a discussion on current pragmatic approaches in the trial population and real world data sources in the post-approval process
- Explore future ideas for long-term follow-up including tokenization, EMR to EDC, and others