Twin Cities Chapter: Communicating Benefit-Risk is Fundamental to Device Approval and Market Adoptio

*Student: $50
RAPS Member: $60
Nonmember: $75

*Fax/email in a completed registration form to get the student rate.

While demonstrating safety and effectiveness is important, sponsors may be missing a key element. That is, “Does the benefit outweigh the risk?” The FDA guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications provides clear direction from FDA on the framework for assessing benefit-risk. 

Using real-world examples, this presentation will provide practice examples for each of the factors that contribute to a positive benefit-risk assessment. It will teach you how to communicate these assessments in marketing applications and advisory panel presentations. 

Upon the presentation’s conclusion, you should be able to: 

• Identify the factors that comprise the benefit-risk assessment 
• Develop key messages necessary to communicate a positive benefit-risk 
• Tailor the benefit-risk messages to each key audience: FDA, advisory panel, payer, patient and health-care-practitioner
• Understand FDA framework

This program is brought to you by the RAPS Twin Cities Chapter and is intended to promote knowledge sharing and engagement with others in the in your region. Dinner will be provided and RAC holders may claim two RAC recertification credits.

Featured Speaker:
Susan Resnick, PhD scientific executive consultant, 3D Communications