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  5. Public Meeting - Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond - 09/29/2020 - 09/29/2020
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Meeting

Event Title
Public Meeting - Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
September 29, 2020


Date:
September 29, 2020
Time:
10:30 AM - 4:45 PM ET

The Food and Drug Administration (FDA), along with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), is announcing the following public meeting entitled "Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond" that will be held by webcast only. The purpose of the public meeting is to discuss and explore potential applications, challenges, and opportunities of using Patient Preference Information.

INTRODUCTION

Patient preference information (PPI) is increasingly being used in regulatory decision making for medical devices. This meeting will provide a forum to engage key stakeholders, including patients, researchers, regulators, payers, and the life sciences industry, to discuss and explore potential applications, challenges, and opportunities of using PPI across the healthcare ecosystem. Topics that will be discussed include the value of including PPI in different settings, case studies highlighting the use of PPI, and methodologies for collecting PPI. Additional topics are outlined in the Preliminary Agenda below. A pre-event webinar "PPI Primer" is available to all online.

DATE AND TIME

This meeting will be held on September 29, 2020, from 10:30 a.m. to 4:45 p.m. (ET) by webcast only.

WEBCAST MEETING LINK

The public meeting will be webcasted live and the link will be provided in your registration confirmation email. The link for archived webcast will be posted on the website for viewing after the meeting.

PRELIMINARY AGENDA

The following Agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

Time Session Topic Speaker(s)
10:30 a.m. - 10:45 a.m. Logistics and Welcome Nancy Berg
Suzanne Schrandt, JD
10:45 a.m. - 11:30 a.m. Introduction and background of patient-preference information (PPI) Brett Hauber, PhD
Anindita Saha, BSE
Christina Webber, PhD
11:30 a.m. - 1:00 p.m. Case Studies for Use of PPI in Medical Device Decision-Making Processes Dan Harfe, MSE, MBA
Barry Liden, JD
Christine Poulos, PhD
Todd Snell, MBA
Kimberly Brown Smith, MD, PhD
Michelle Tarver, MD, PhD
1:00 p.m. - 1:30 p.m. Lunch Break  
1:30 p.m. - 3:00 p.m. Methodologic Issues for PPI Studies Ryan Fischer
David Gebben, PhD
Juan Marcos González, PhD
Bennett Levitan, MD, PhD
Shelby Reed, RPh, PhD
3:00 p.m. - 3:15 p.m. Break  
3:15 p.m. - 4:30 p.m. Implementation / Process of Obtaining and Using PPI - the 'Beyond' Dean Bruhn-Ding
Louis Jacques, MD
Ravi Jayadevappa, PhD
Melissa West
Lucinda Orsini, DPM, MPH
4:30 p.m. - 4:45 p.m. Closing Remarks Michelle Tarver, MD, PhD
4:45 p.m. Adjourn  

REGISTRATION

Please visit the ISPOR website to register for the webcast meeting.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.

CONTACT

For questions regarding meeting content please contact:

Michelle Tarver, MD, PhD
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
301-796-6884
Email: CDRH-PPI@fda.hhs.gov  

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