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Session 8: Panel Discussion on Human Factors for Combination Product Development and Closing Remarks
Session Chair(s)
Karthik Balasubramanian, PhD, MS
VIce President, CMC & Technical Operations
Verrica Pharmaceuticals, United States
Karl Saldanha, PhD
Associate Regulatory Program Director
United States, United States
This session offers the opportunity for industry and FDA Human Factors (HF) leaders to offer their viewpoints and experiences regarding the role of HF in the development of drug-device combination products. Topics discussed will focus on the HF engineering process and its integration within the overall design controls process. In particular, the session will focus on use of formative studies to inform combination product design, as well as key considerations in HF validation study design, execution, and analysis of results. In addition, panelists will discuss the use of comparative/threshold analysis and associated studies. The session will offer the audience an opportunity to interact directly with the panelists and ask questions.
Learning Objective : - Identify the role HF engineering plays in combination product development and the design controls process
- Discuss the intent of formative assessments and how they are performed
- Recognize key considerations in HF validation study design, execution, and analysis of results
- Apply use of comparative/threshold analysis and associated studies
- Define key regulatory expectations for HF in combination products
Speaker(s)
Panelist
Christina Mendat Mendat, PhD
Human Factors MD, United States
Managing Director
Panelist
Shannon Hoste, MS
Agilis Consulting Group, United States
President
Panelist
Paul Blowers, MA
AbbVie Inc., United States
Director, Human Factors - Drug Delivery Solutions
Panelist
Irene Z. Chan, PharmD
FDA, United States
Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,
Closing Remarks
James Wabby, MHS
AbbVie, United States
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
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