Introduction to the EQIPD quality system

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DOI

  • Anton Bespalov, PAASP
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  • René Bernard, Department of Experimental Neurology, Center of Stroke Research, Charité Universitätsmedizin
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  • Anja Gilis, Janssen Pharmaceutica NV, Moscow, Russia.
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  • Björn Gerlach, PAASP
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  • Javier Guillén, AAALAC International
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  • Vincent Castagné, Porsolt
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  • Isabel A Lefevre, Rare and Neurologic Diseases Research
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  • Fiona Ducrey, Integrity and Global Research Practices
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  • Lee Monk, New Medicines, UCB Pharma, Slough, United Kingdom.
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  • Sandrine Bongiovanni, Novartis Institutes for BioMedical Research, Novartis Pharma AG, Basel, Switzerland.
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  • Bruce Altevogt, Pfizer Oncology, Pfizer Inc., New York, NY, USA.
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  • María Arroyo-Araujo, University Medical Center Groningen, University of Groningen, Groningen
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  • Lior Bikovski, Netanya Academic College, Tel Aviv University
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  • Natasja de Bruin, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
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  • Esmeralda Castaños-Vélez, Department of Experimental Neurology, Center of Stroke Research, Charité Universitätsmedizin
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  • Alexander Dityatev, German Center for Neurodegenerative Diseases, Otto von Guericke University Magdeburg
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  • Christoph H Emmerich, PAASP
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  • Raafat Fares, Charles River Laboratories
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  • Chantelle Ferland-Beckham, Cohen Veterans Bioscience
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  • Christelle Froger-Colléaux, Porsolt
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  • Valerie Gailus-Durner, German Research Center for Environmental Health
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  • Sabine M Hölter, Technical University of Munich
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  • Martine Cj Hofmann, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
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  • Patricia Kabitzke, PAASP US
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  • Martien Jh Kas, University Medical Center Groningen, University of Groningen, Groningen
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  • Claudia Kurreck, Department of Experimental Neurology, Center of Stroke Research, Charité Universitätsmedizin
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  • Paul Moser, Cerbascience, PAASP
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  • Malgorzata Pietraszek, PAASP
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  • Piotr Popik, Polish Acad Sci, Polish Academy of Sciences, Institute of Nuclear Physics - Polish Academy of Sciences, Henryk Niewodniczanski Inst Nucl Phys
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  • Heidrun Potschka, Ludwig-Maximilians-University, Munich
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  • Ernesto Prado Montes de Oca, Research Center inTechnology and Design Assistance of Jalisco State, Scripps Research Institute
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  • Leonardo Restivo, Center for BioMedical Imaging, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
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  • Gernot Riedel, Aberdeen Biomedial Imaging Centre, University of Aberdeen
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  • Merel Ritskes-Hoitinga
  • Janko Samardzic, University of Belgrade
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  • Michael Schunn, Institute of Science and Technology Austria, Klosterneuburg, Austria.
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  • Claudia Stöger, Institute of Human Genetics, Helmholtz Zentrum München - German Research Center for Environmental Health, Neuherberg, 85764, Germany.
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  • Vootele Voikar, Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland.
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  • Jan Vollert, Imperial Coll London, Imperial College London, Imperial Clin Trials Unit
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  • Kimberley E Wever, Radboud University Medical Center
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  • Kathleen Wuyts, Avertim
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  • Malcolm R MacLeod, Edinburgh University, Edinburgh
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  • Ulrich Dirnagl, Department of Experimental Neurology, Center of Stroke Research, Charité Universitätsmedizin
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  • Thomas Steckler, Janssen Pharmaceutica NV, Moscow, Russia.

While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union's Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.

Original languageEnglish
Article numbere63294
JournaleLife
Volume10
Number of pages26
ISSN2050-084X
DOIs
Publication statusPublished - May 2021

Bibliographical note

© 2021, Bespalov et al.

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