Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project

Author:

de Bekker-Grob Esther W.,Berlin Conny,Levitan Bennett,Raza Karim,Christoforidi Kalliopi,Cleemput Irina,Pelouchova Jana,Enzmann Harald,Cook Nigel,Hansson Mats G.

Publisher

Springer Science and Business Media LLC

Reference9 articles.

1. Hoos A, Anderson J, Boutin M, et al. Partnering with patients in the development and lifecycle of medicines: a call for action. Ther Innov Regul Sci. 2015;49:929–39.

2. Smith MY, Hammad TA, Metcalf M, et al. Patient engagement at a tipping point—the need for cultural change across patient, sponsor, and regulator stakeholders: insights from the DIA conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products”. Ther Innov Regul Sci. 2016;50:546–53.

3. Medical Device Innovation Consortium (MDIC) Patient-Centered Benefit-Risk Project report. http://mdic.org/wp-content/uploads/2015/05/MDIC_PCBR_Framework_Web.pdf . Accessed 20 Feb 2017.

4. The IMI PREFER project. http://www.imi-prefer.eu/ . Accessed 20 Feb 2017.

5. US Department of Health and Human Services. Food and Drug Administration. Center for Devices and Radiological Health. Center for Biologics Evaluation and Research. Patient Preference Information—Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labelling. Guidance for industry, food and Drug Administration Staff, and Other Stakeholders. 24 August 2016. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM446680.pdf . Accessed 20 Feb 2017.

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