Name: Philadelphia Chapter In Person Event: Navigating Evolving Topics in Combination Products: Human Factors Considerations, EDDOs, and Post Approval Device Changes
Start: 2026-04-29T17:30:00
End: 2026-04-29T20:00:00
Location: Exponent (One uCity Square)

Philadelphia Chapter In Person Event: Navigating Evolving Topics in Combination Products: Human Factors Considerations, EDDOs, and Post Approval Device Changes

Join us for a panel discussion about the unique considerations that can impact regulatory activities throughout the lifecycle of a combination product with a device constituent part for delivery of a drug or biologics.

5:30pm – 8pm EDT April 29, 2026 + Add to calendar Philadelphia, PA Exponent (One uCity Square)

Development of a combination product with a device constituent part for delivery of a drug or biologic warrants unique considerations that can impact regulatory activities throughout the total product life cycle. Join us for a panel discussion with regulatory and technical experts who will discuss topics related to:

Essential Drug Delivery Outputs (EDDOs) (FDA Draft Guidance)
Use-Related Risk Analyses and Application of Human Factors Engineering Principles for Combination Products (FDA Guidance)
Lifecycle Management while navigating changes to the device components after initial marketing authorization in the EU (EMA Q&A)

A set of live demonstrations using a simulated on-body delivery device will also be featured. These live demonstrations will include: a simulated failure of an on-body delivery device, failure analysis of the failed on-body delivery device, MRI compatibility assessment, and a simulated usability study.

Location

Exponent (One uCity Square)
25 N 38th St
Ste. 700
Philadelphia, PA 19104

Cancellations and Refunds

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. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.