Register for the April 11 FDA Grand Rounds and discover the benefit-risk approaches FDA uses to make tough regulatory decisions: CE credit available

Register for the April 11 FDA Grand Rounds and get CE Credit: What  benefit-risk assessment tools does FDA use to make tough regulatory decisions?

Thursday, April 11, 2019

12:00 p.m. - 1:00 p.m. EST

 

Register here for webcast (public attendees and FDA staff)

 

Presented by: 

Richard A. Forshee, PhD

Associate Director for Research

Office of Biostatistics and Epidemiology 

FDA's Center for Biologics Evaluation and Research (CBER)

About the Presentation:

FDA often faces uncertainty in making significant public health decisions--and yet the decisions must be made. The agency must frequently consider data and analyses from disparate sources, from randomized clinical trials to passive surveillance when deciding on product approval or regulatory policy.  Formal benefit‒-risk assessment approaches can help FDA decision-makers understand how the key sources of uncertainty affect their decisions and help to integrate different types of data and analyses into their deliberations.

FDA’s Dr. Richard Forshee will present key benefit-risk assessment concepts and tools, giving examples where formal benefit-risk assessment has supported difficult public health decisions.

What you’ll learn from this FDA scientist: 

• How formal benefit‒risk assessment approaches can identify key areas of uncertainty in a public health decision
• How benefit-risk assessment approaches can improve the communication of public health decisions and predict circumstances where these might be best applied.
• How observational data and other sources of Real World Evidence can support public health decisions.