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Course Information
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 Patient-Focused Medical-Product Development
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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