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How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development
Session Chair(s)
Pujita Vaidya, MPH
Director, Regulatory Science and Policy
Sanofi, United States
A multi-stakeholder panel will discuss: regulatory pathways and consideration for early engagement with regulators, harmonization efforts to standardize use of PED, present frameworks to support Industry planning, and explore future opportunities.
Learning Objective : Discuss regulatory pathways for early engagement to streamline PFDD; Examine regulatory considerations and harmonization efforts to standardize the collection and use of Patient Experience Data; Recognize how to evaluate frameworks available to support industry planning of PFDD studies; Describe best practices for ensuring successful patient-focused study planning and regulatory decision-making.
Speaker(s)
FDA Perspective
Valentina Mantua
FDA, United States
Associate Director of Regulatory Science, OND, CDER
Patient-Experience Data in Development Programs and Regulatory Decision-Making
Juan Garcia-Burgos, MD, PhD
European Medicines Agency, Netherlands
Head of Public and Stakeholders Engagement Department
Patient Representative Perspective and Resources for Advancing PFDD
Silke Schoch, MA
National Health Council, United States
Director, Research & Programs
Industry Perspective
Samantha Roberts, PhD
AstraZeneca, United States
Senior Director, Regulatory Intelligence
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