RAPS Chicago Chapter: The Patient Perspective: Patient Influence on US FDA

Join regulatory colleagues from your region for an evening of networking and an interactive presentation on how FDA is increasing meaningful patient engagement, such as patient-reported outcomes, as one of its top strategic priorities. This program is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with other in the local regulatory community.

Engaging with patients continues to be a top priority for US FDA as it tries to determine what device users want and its value when it comes to healthcare. Patient-perspective studies can provide valid scientific evidence regarding patients’ risk tolerance and perspective on benefit. The studies also can inform FDA’s evaluation of a device’s benefit-risk profile during the premarket approval (PMA), humanitarian device exemption (HDE) application and de novo request review processes.

Topics to be covered by Ricki Chase, former FDA investigations branch director will include:

• How the patient is playing a larger role in the medical device regulatory and compliance scheme
• How human factors are viewed in combination devices
• The top 483 observations in drugs and devices and the reasons why they never seem to change
• And how to best communicate with FDA in the changing landscape of program alignment and deeper center influence over field operations.

Dinner will be provided. RAC holders may claim two RAC recertification credits.