Loading…
← Back to schedule
#364: Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-660-L04-P; CME 1.00; RN 1.00

This session will provide an opportunity for key stakeholders, including regulators, product developers and patients to discuss best practices around patient experience data, including planning, collecting, and submitting such data to regulators.

Learning Objectives

Discuss current expectations for regulator/sponsor interactions related to patient experience data that will be used in regulatory submissions; Recognize common pitfalls for submission of patient experience data in regulatory applications, and how to avoid them.

Chair

Robyn Bent, BSN, MS, RN

Speaker

Panelist
Pujita Vaidya, MPH

Panelist
Brett Hauber, PhD, MA


Speakers
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →
avatar for Brett Hauber

Brett Hauber

Patient Preference Evidence Integration Lead, Pfizer Inc, United States
avatar for Pujita Vaidya

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States
Pujita Vaidya has 12+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Forum |   09: Regulatory, Forum

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share
Need help? View Support Guides
Event questions? Contact Event Planner
Powered by Sched Event Planning App
©2025 Sched • About • Privacy • Terms
Share Modal

Share this link via

Or copy link