Loading…
← Back to schedule
#141: 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
202A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-539-L04-P; CME 1.00; RN 1.00

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; 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.

Chair

Pujita Vaidya, MPH

Speaker

FDA Perspective
Valentina Mantua

Patient-Experience Data in Development Programs and Regulatory Decision-Making
Juan Garcia-Burgos, MD, PhD

Patient Representative Perspective and Resources for Advancing PFDD
Silke Schoch, MA

Industry Perspective
Samantha Roberts, PhD


Speakers
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Juan García Burgos is a Qualified Medical Doctor specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development... Read More →
VM

Valentina Mantua

Associate Director of Regulatory Science, OND, CDER, FDA, United States
avatar for Samantha Roberts

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States
Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →
SS

Silke Schoch

Director, Research & Programs, National Health Council, United States
Silke Schoch is the Director of Research & Programs at the National Health Council. Ms. Schoch joined the National Health Council in 2017 and has been a project manager for many of the NHC’s patient engagement-focused projects including the Patient Experience Mapping Toolbox and... Read More →
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 →
Monday June 16, 2025 3:45pm - 4:45pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

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