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Virtual

Jan 26, 2021 9:45 AM - Jan 28, 2021 5:00 PM

(US Eastern Standard Time)

Pharmacovigilance and Risk Management Strategies Conference

Session 12: Pharmacovigilance Approaches for Drug-Device Combination Products

Session Chair(s)

Jo  Wyeth, PharmD

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)

Melissa  Burns, MS

Combination Product Postmarketing Safety Reporting Requirements Implementation Update

Melissa Burns, MS

FDA, United States

Senior Program Manager, Office of Combination Products, OCPP, OC

Jason  Flint, MBA, PMP

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

James  Duhig, PhD

Speaker

James Duhig, PhD

AbbVie, United States

Global Head, Office of Health Literacy

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