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dc.contributor.authorPerfetto, Eleanor M.
dc.contributor.authorOehrlein, Elisabeth Maria
dc.date.accessioned2019-07-23T18:23:01Z
dc.date.available2019-07-23T18:23:01Z
dc.date.issued2015
dc.identifier.urihttp://hdl.handle.net/10713/10123
dc.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.en_US
dc.description© 2015 University of Maryland, Baltimore. School of Pharmacyen_US
dc.description.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.en_US
dc.description.sponsorshipFunding 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.en_US
dc.language.isoen_USen_US
dc.subjectpatient-centereden_US
dc.subjectpatient focuseden_US
dc.subjectpatient involvementen_US
dc.subjectregulatory reviewen_US
dc.subjectreimbursementen_US
dc.subjectPrescription Drug User Fee Act (PDUFA)en_US
dc.subject.lcshDrug approvalen_US
dc.subject.meshDrug Developmenten_US
dc.subject.meshPatient Participationen_US
dc.titleMaryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) Conference 2015: Assessing Meaningful Patient Engagement in Drug Development: A Definition, Framework, and Rubricen_US
dc.title.alternativeM-CERSI Conference 2015: Assessing Meaningful Patient Engagement in Drug Development: A Definition, Framework, and Rubricen_US
dc.title.alternativeAssessing Meaningful Patient Engagement in Drug Development: A Definition, Framework, and Rubricen_US
dc.typeArticleen_US
refterms.dateFOA2019-07-23T18:23:01Z


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