HEOR Learning Lab™ is an educational resource for professionals who work or have an interest in the field of health economics and outcomes research (HEOR). This resource provides unlimited, on-demand, educational video content to
facilitate learning and innovative approaches in the field from the leading global organization in HEOR.
ISPOR members can immediately access everything that HEOR Learning Lab offers and that includes high-value content selected from the Society’s conferences, summits, and other seminal events. Content is focused on the most topical themes impacting the field, including real-world evidence, patient-centered research, digital health, artificial intelligence and machine learning, health technology assessment, economic methods, healthcare financing, access and policy, learning healthcare systems, and much more. Nonmembers can gain access by either becoming a member or subscribing to HEOR Learning Lab.
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February 2, 2023
Open to all ISPOR Members and Non-members
Title: FDA Patient-Focused Drug Development (PFDD) Guidance
10:00AM EST | 3:00PM UTC | 4:00PM CET
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Register Now
Description
This is part one of a two-part webinar series. The FDA is developing Patient-Focused Drug Development (PFDD) guidance to inform the inclusion of patient experience when developing new medical therapies and products. This is a four-part guidance series, with two final guidances released, a third draft
guidance released and a fourth guidance under development. The PFDD guidance is anticipated to be influential in the field of health economics and outcomes research. In this webinar series, we will hear from patients and FDA staff to learn what is
covered in this guidance series and what these new guidances mean for patient-focused drug development.
Learning Objectives
• Inform the ISPOR membership about the FDA PFDD initiative in general and the
four PFDD Guidances more specifically, and the various ways PFDD might impact the work they do in HEOR, COA, regulatory science, and other areas.
• Provide background on what led up to the legislation that mandated guidance preparation.
• Provide insights on how the guidances can be used.
• Understand the impact and importance of the Use of Patient Experience Data in Regulatory Decision-Making and its integration.
Resources
It is suggested to review these resources prior to participating in the webinar.
- Assessment of the Use of Patient Experience Data in Regulatory Decision-Making | FDA
- Guidance Overview - FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
- Finalized Guidance 1 - Collecting Comprehensive and Representative Input
- Finalized Guidance 2 - Methods to Identify What is Important to Patients
- Draft Guidance 3 - Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Moderator:
Eleanor Perfetto, BS, MS, PhD, Professor, Department of Practice, Science, and Health Outcomes Research, University of Maryland, Baltimore, MD, USA
Speakers:
Annie Kennedy, Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, Washington, DC, USA
Selena Daniels, PharmD, PhD, Clinical Outcome Assessment Team Leader, Food & Drug Administration (FDA), Washington, DC, USA
Please note: On the day of the scheduled webinar, the
first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the
full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.