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How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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 Objectives

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; Evaluate frameworks available to support industry planning of PFDD studies; highlight best practices for ensuring successful patient-focused study planning and regulatory decision-making.

Chair

Pujita Vaidya, MPH

Speaker

How Soon is Too Soon? Enhancing Early Regulatory Engagement to Streamline Patient-Focused Drug Development
Pujita Vaidya, MPH


Speakers
avatar for Pujita Vaidya

Pujita Vaidya

Director, US Patient Engagement, Novartis Pharmaceuticals Corporation, United States
Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies (e.g., Patient Centricity, Pediatrics, and Innovative Trials). Her work includes partnering with cross-functional colleagues... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

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