×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development
Session Chair(s)
Pujita Vaidya, MPH
North America Lead, 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; Evaluate frameworks available to support industry planning of PFDD studies; highlight best practices for ensuring successful patient-focused study planning and regulatory decision-making.
Speaker(s)
Patient-Experience Data in Development Programs and Regulatory Decision-Making
Representative Invited
European Medicines Agency, Netherlands
How Soon is Too Soon? Enhancing Early Regulatory Engagement to Streamline Patient-Focused Drug Development
Pujita Vaidya, MPH
Sanofi, United States
North America Lead, Regulatory Science and Policy
Have an account?