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Monday, June 15 • 11:00am - 12:00pm
#107 L: Patients First! How FDA is Making Patients a Priority

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore/discuss Agency-wide patient engagement programs/initiatives that provide patient stakeholders opportunities to engage with FDA and participate in regulatory discussions that inform medical product development and review. Join the DIA Patient Engagement Community for a follow up round table discussion (session #112 L-RT) on Monday, June 15, 12:30PM - 1:30PM.

Learning Objectives

Describe components established focused on making patients a priority; Describe avenues for patient stakeholders to engage with the agency; Review key initiatives where patient stakeholders can share their experiences to help inform medical product development; Discuss value added from patient stakeholder participation.

Chair

Andrea Furia-Helms, MPH

Speaker

Panelist
Diane Maloney, JD

Panelist
Michelle Tarver, MD, PhD

Panelist
Sadhna Khatri, PharmD, MEd, MPH, MSc

Panelist
Philip Posner, PhD



Speakers
avatar for Andrea Furia-Helms

Andrea Furia-Helms

Director, Patient Affairs Staff, OC, FDA, United States
Andrea Furia-Helms is the Director of the Patient Affairs Staff in the Office of the Commissioner at FDA. She works closely with the medical product centers and other offices to coordinate cross-cutting patient engagement activities and ensure patients, caregivers, and advocates have... Read More →
DM

Diane Maloney

Associate Director for Policy, CBER, FDA
Diane Maloney, J.D., is the Associate Director for Policy, Office of the Director, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). She oversees regulation and policy development for CBER as well as the Center’s participation on cross-cutting... Read More →
avatar for Sadhna Khatri

Sadhna Khatri

Regulatory Officer, PASES, OCD, CDER, FDA
CDR Sadhna Khatri, PharmD, MPH, is a regulatory officer in Professional Affairs and Stakeholder Engagement (PASE) in the Office of the Center Director in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). She is the Supervisor of the PASE Engagement... Read More →
avatar for Philip Posner

Philip Posner

Retired Academic, Patient Representative
Dr. Posner is a patient with MS and Atrial Fibrillation He has been involved in research and teaching at several major institutions. He has served as a patient representative for the FDA and P.C.O.R.I. He also volunteers with the National Capitol MS Society through various programs... Read More →
avatar for Michelle Tarver

Michelle Tarver

Director for Patient Science and Engagement, DAHRSSP, CDRH, FDA, United States
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Her program interacts with digital health... Read More →


Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Session