Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Engage with key regulators and partners in practical approaches to navigate regulatory requirements, enhance collaboration and accelerate combination product development.

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Session 5: Human Factors and Other Common Device Deficiencies

Session Chair(s)

Kirsten H. Paulson, MS, RAC

Pfizer, Inc., United States

FDA reviewers will discuss experience with review of human factors study protocols and common misconceptions or deficiencies. Discuss how FDA coordinates review of Instructions for Use with IFU validated through usability testing, and varying HF expectations between FDA centers.

Speaker(s)

PANELISTS - Human Factors Issues Combination Products – A Case Study

Patricia Love, MD, MBA

FDA, United States

Deputy Director, Office of Combination Products, OCPP, OC

Lessons Learned for Combination Product Design and Labeling

Irene Z. Chan, PharmD

FDA, United States

Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,

Drug and Device CombinationProducts 2015

Kathleen E. O'Sullivan, MS, RAC

BD Medical - Diabetes Care, United States

Worldwide Director, Regulatory Affairs

Lessons Learned from Human Factors Reviews of Premarket Submissions at FDA’s Center for Devices and Radiological Health (CDRH)

Shannon Hoste, MS

Agilis Consulting Group, United States

President

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