Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) Conference 2015: Assessing Meaningful Patient Engagement in Drug Development: A Definition, Framework, and Rubric
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Other TitlesM-CERSI Conference 2015: Assessing Meaningful Patient Engagement in Drug Development: A Definition, Framework, and Rubric
Assessing Meaningful Patient Engagement in Drug Development: A Definition, Framework, and Rubric
AbstractA movement to include the patient voice in health care research and decision making is underway. In light of broad stakeholder interest in patient-focused drug development (PFDD), a range of stakeholders are considering approaches to increase the scope of PFDD and enhancing patient engagement. On March 9, 2015, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), with the support of many partner organizations, held the “M-CERSI Conference on PatientFocused Drug Development.” The objective was to allow stakeholders from patient groups, the US Food and Drug Administration (FDA), the biopharmaceutical industry, payer, and other organizations to voice their views on, activities in, and aspirations for PFDD. During the day-long program, participants discussed the challenges to successful PFDD including regulatory challenges, the patient and patient advocate role, the emerging payer role, along with future directions and opportunities for collaboration. This document summarizes the outputs of the conference including a suggested definition, rubric, and framework for PFDD.
DescriptionHeld on March 9, 2015, the M-CERSI Conference on Patient-Focused Drug Development provided a forum for all patient-focused drug development (PFDD) stakeholders to gather for an open dialogue.
© 2015 University of Maryland, Baltimore. School of Pharmacy
SponsorsFunding for the conference was provided by the University of Maryland Center of Excellence in Regulatory Science and Innovation, AstraZeneca, Global CEO Initiative on Alzheimer’s Disease, Merck, Novartis, Pfizer, Sanofi, and UCB.
Prescription Drug User Fee Act (PDUFA)
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/10123
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