Tag Archives: Modeling and Simulation

26Jun/19
Digital Evidence Webinar

FDA Discusses the Use of Digital Evidence to Accelerate Innovation

A Straight from the Source Webinar

FDA is encouraging the use of “Digital Evidence to accelerate product innovation supporting rapid introduction of life-saving technology for patients “Digital evidence” is already being used at FDA to predict clinical outcomes, inform clinical trial design, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on July 10 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital and real world evidence  
  • Modeling and Simulation to support improved quality and patient outcomes 
  • Examples of Digital Evidence currently in use at FDA 
  • The Review of the Futureharnessing the power digital and real world evidence through digital transformation 

Meet Your Trusted Sources

Tina and Dan for CC

Over 200 FDA employees are part of the Agency’s Modeling and Simulation working group. Find out what they are working on and more.  

Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

register

13Sep/18
Brain - small - low res

Survey: Modeling and Simulation in Life-Sciences

Tina Morrison, PhD, Deputy Director, Division of Applied Mechanics and Chair of FDA’s Modeling and Simulation Working Group recently presented initiatives underway at the agency to advance the use of Modeling and Simulation.
FDA routinely advises industry on using modeling and simulation to, for example:
  • Predict clinical outcomes
  • Inform clinical trial designs
  • Support evidence of effectiveness
  • Identify the most relevant patients to study
  • Predict product safety
Axendia would appreciate your input on a survey that focuses on the current use and perceived value of Modeling and Simulation in Life-Sciences.

The survey should take no longer than 10 minutes to complete and all individual responses will be kept strictly confidential.  You are also welcome to register to receive a copy of the survey outcome.