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Course Information
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Over the past decade, the role of
patients as partners in medical-product development has increased.
Additionally, Food and Drug Administration (FDA) regulatory guidance on
Patient-Focused Drug Development and the European Medicines Agency’s (EMA)
patient input system, further indicate increasing industry-wide focus on how to
collect and apply representative patient experience data (PED). The intent
being to inform the development and evaluation of medical products across the
product lifecycle, including health technology assessment (HTA). Health
economics and outcomes research (HEOR) stakeholders, including ISPOR members,
are actively seeking to meaningfully partner with patients to incorporate PED
into their research.
After the completion of this course,
participants will be able to: *Understand
patient engagement in medical-product research and its development by defining
the terms, providing historical context, and illustrating its significance
throughout ISPOR’s HEOR taxonomy. *Use
tools to plan and implement meaningful patient engagement activities in their
respective areas of research (e.g., clinical development, epidemiology, health
economics, real-world evidence, etc.). *Provide
solutions for addressing challenges in implementing patient engagement in a
clinical research environment. *Describe
real-world examples of patient-researcher partnerships, best practices, and
practical solutions to challenges.
The access period once enrolled into the course is 60 days from the date of purchase. After this duration, you will need to re-enroll if you wish to re-enter the course. Time to complete – approximately 4-6 hours HEOR Key Competencies12.1 Patient-Reported Outcomes (PRO) Development, Including Psychometrics (learn more)
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Speakers
Allison Martin Nguyen
Organization: Merck & Co. Inc
Elisabeth Oehrlein
Organization: Applied Patient Experience, LLC
Mary Schrandt
Organization: ExPPect
Robert McBurney
Organization: Accelerated Cure Project for MS
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Fees
- Course: Patient-Focused Medical-Product Development Non Member Price: $340.00
- Course: Patient-Focused Medical-Product Development Member Price: $255.00
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