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Session 12: Pharmacovigilance Approaches for Drug-Device Combination Products
Session Chair(s)
Jo Wyeth, PHARMD
Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER
FDA, United States
Novel drug-device combination products are expected to continue entering the global marketplace and provide great opportunities for clinical benefit. These types of products also introduce challenges in pharmacovigilance for integrating device and drug product expertise, gathering and coding adverse event, device malfunction, and medication error information, and deciphering possible relationships with the drug, device, or product itself. This session will use a case-based approach to glean perspectives from regulators and industry on assessing reports of suspected device malfunction versus use errors with drug-device combination products.
Learning Objective :
- Describe the role of human factors engineering in designing drug-device combination products with a user interface that supports safe and effective use
- Propose an effective approach for surveilling suspected use errors versus malfunction with drug-device combination products
- Discuss strategies to increase efficiency for gathering, coding, and evaluating postmarket information involving drug-device combination products
Speaker(s)
Combination Product Postmarketing Safety Reporting Requirements Implementation Update
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC
Human Factors in Medical Product Design & Development : Post-market Considerations
Jason Flint, MBA, PMP
FDA, United States
Associate Director for Human Factors Reviewer, CDER, OSE, OMERPM, DMEPA
Speaker
James Duhig, PHD
AbbVie, United States
Global Head, Office of Health Literacy