Join FDA’s Tina Morrison and Axendia’s Daniel R. Matlis for a live webinar on September 18th at 11:00 AM ET.
FDA is encouraging the use of “Digital Evidence” to inform clinical trial designs, predict clinical outcomes, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions.
Digital evidence from in silico clinical trials have been shown to produce similar results as human clinical trials and under certain circumstances may replace clinical evidence.
We will discuss FDA’s perspective on:
* Shifting from traditional evidence sources to digital evidence
* How to create virtual patients with digital evidence to replace clinical evidence
* Examples of digital evidence in Pharma and Medical Device used in FDA to initiate and augment clinical studies
* Creating an in silico clinical trial Playbook
* Why data in PDF’s are not sufficient
Can't make this time? Register and you will be able to watch the On-Demand recording after the event.