Following the FDA’s recent announcement postponing meetings in response to COVID-19, the ISPOR-FDA Summit is postponed to a later date that will be announced once available. Learn More

Program


Please note that this schedule is specific to the previously scheduled date of the summit. Sessions, speakers and times may change with the new date.
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March 31, 2020

7:30 AM - 8:30 AM

Registration: ISPOR-FDA Summit 2020

  • Description
  • In person summit registration.

March 31, 2020

8:30 AM - 8:45 AM

Welcome

  • Description


March 31, 2020

8:45 AM - 10:00 AM

Session 1: Introduction to and Background of Patient-Preference Information (PPI)

  • Description
  • This session will provide an overview of PPI and the various terms referenced in this field. This will include a discussion on the fundamentals of how PPI differs from other types of patient-provided information and the different types of regulatory decisions that can be informed by PPI. A review of current regulatory documents that involve PPI, as well as an explanation of the quality measures considered by CDRH will be presented.


March 31, 2020

10:00 AM - 10:15 AM

Break

March 31, 2020

10:15 AM - 12:15 PM

Session 2: Case Studies for Use of PPI in Medical Device Decision-Making Processes

  • Description
  • This session will be comprised of 4 separate case study presentations involving PPI. The cases will offer insights into the reason or indication for the PPI study, problems/challenges that were successfully addressed or unsuccessfully resolved, and a summary of the overall outcomes and lessons learned. Time for audience Q/A will follow at the end of the session.


March 31, 2020

12:15 PM - 1:15 PM

Lunch: ISPOR-FDA Summit 2020

March 31, 2020

1:15 PM - 2:45 PM

Session 3: Methodologic Issues for PPI Studies

  • Description
  • This session will involve 4 distinct presentations on methodologic considerations associated with regulatory decisions in PPI studies, including strategies that have and have not been successful, inclusion of heterogeneity of preferences in studies and regulatory submissions, and overall summaries of what’s worked and what hasn’t worked methodologically. Time for audience Q/A will follow at the end of the session.


March 31, 2020

2:45 PM - 3:00 PM

Break

March 31, 2020

3:00 PM - 4:15 PM

Session 4: Implementation / Process of Obtaining and Using PPI – the ‘Beyond’

  • Description
  • This session will focus on the implementation of PPI studies and the process of obtaining and using PPI through discussion amongst a multi-stakeholder panel. Topics for discussion include identification of challenges or barriers present in the process, where PPI has been or could be collected along the product lifecycle, how and where information from PPI studies has been used outside of regulatory decision-making processes.  Time for audience Q/A will follow at the end of the session.



March 31, 2020

4:15 PM - 4:30 PM

Closing Remarks

  • Description
  • This session will reflect on the day’s discussion and suggest next steps to continue to advance the utilization of PPI in medical devices.



March 31, 2020

4:30 PM - 4:30 PM

Summit Adjourned