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Thursday, June 18 • 8:00am - 9:00am
#404 L: Incorporating Patient Input into Medical Product Development and the US Food and Drug Administration’s Decision-Making

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-558-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will provide an opportunity for key stakeholders, including regulators, product developers and patients, to discuss the incorporation of patient input into medical product development and regulatory decision-making.

Learning Objectives

Describe current and upcoming efforts across FDA’s medical product centers to advance the incorporation of patient input into medical product development and FDA’s regulatory decision-making; Describe considerations that should be addressed in order to realize the full potential for patient input to support medical product development and regulatory decision-making.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Robyn Bent, MS, RN

Panelist
Michelle Tarver, MD, PhD

Panelist
Martin Ho, MS



Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Lead, Science Strategies, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development Program, OCD, CDER, FDA, United States
Robyn Bent joined the US FDA in 2019 as the director of CDER’s Patient-Focused Drug Development (PFDD) Initiative, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making... Read More →
avatar for Martin Ho

Martin Ho

Associate Director, Office of Biostatistics and Epidemiology, CBER, FDA
Mr. Martin Ho is Associate Director of Quantitative Patient Inputs & Real-World Patient Evidence at Office of Biostatistics & Epidemiology, CBER, US FDA. Prior, he was the Director of Quantitative Innovation at Center for Devices, turning new data sources into regulatory-grade evidence... 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 →


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum