RAPS Member: $60
*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. Topics to covered will include:
- 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.
Susan Resnick, PhD, scientific executive consultant, 3D Communications
Local contact: Lena Cordie-Bancroft, Twin Cities Chapter Chair
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.
Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at email@example.com.