Menu Back toSession 8: Panel Discussion on Human Factors for Combination Product Development and Closing Remarks

Combination Products Conference

Now offering a preconference Primer on October 14


Session 8: Panel Discussion on Human Factors for Combination Product Development and Closing Remarks

Session Chair(s)

Karthik  Balasubramanian, PhD, MS

Karthik Balasubramanian, PhD, MS

  • Director, Combination Products and Semisolids, Generic CPD
  • Teva Pharmaceuticals, United States
Karl  Saldanha, PhD

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)

Christina Mendat Mendat, PhD

Panelist

Christina Mendat Mendat, PhD

  • Managing Director
  • Human Factors MD, United States
Shannon  Hoste, MS

Panelist

Shannon Hoste, MS

  • Senior Director, Development Quality and Human Factors Engineering
  • Enable Injections Inc., United States
Paul  Blowers, MA

Panelist

Paul Blowers, MA

  • Director, Human Factors - Drug Delivery Solutions
  • AbbVie Inc., United States
Irene Z. Chan, PharmD

Panelist

Irene Z. Chan, PharmD

  • Deputy Director, Division of Medication Error Prevention and Analysis, OSE, CDER
  • FDA, United States
James  Wabby, MHS

Closing Remarks

James Wabby, MHS

  • Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
  • Abbvie, United States