IT/QA and Regulatory Aspects of Digital Pathology: Results of the 8th ESTP International Workshop.

Digital toxicologic histopathology has been broadly adopted in preclinical compound development for informal consultation and peer review. There is now increased interest in implementing the technology for good laboratory practice-regulated study evaluations. However, the implementation is not straightforward because systems and work processes require qualification and validation, with consideration also given to security. As a result of the high-throughput, high-volume nature of safety evaluations, computer performance, ergonomics, efficiency, and integration with laboratory information management systems are further key considerations. The European Society of Toxicologic Pathology organized an international expert workshop with participation by toxicologic pathologists, quality assurance/regulatory experts, and information technology experts to discuss qualification and validation of digital histopathology systems in a good laboratory practice environment, and to share the resulting conclusions broadly in the toxicologic pathology community.

Introduction to the EQIPD quality system.

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.

Quality Governance in Biomedical Research.

Quality research data are essential for quality decision-making and thus for unlocking true innovation potential to ultimately help address unmet medical needs.The factors influencing quality are diverse. They depend on institution type and experiment type and can be of both technical and cultural nature. A well-thought-out governance mechanism will help understand, monitor, and control research data quality in a research institution.In this chapter we provide practical guidance for simple, effective, and sustainable quality governance, tailored to the needs of an organization performing nonregulated preclinical research and owned by all stakeholders.GLP regulations have been developed as a managerial framework under which nonclinical safety testing of pharmaceutical and other products should be conducted. One could argue whether these regulations should be applied to all nonclinical biomedical studies. However, the extensive technical requirements of GLP may not always be fit to the wide variety of studies outside the safety arena and may be seen as overly prescriptive and bureaucratic. In addition, GLP regulations do not take into account scientific excellence in terms of study design or adequacy of analytical methods. For these reasons and in order to allow a lean and fit for purpose approach, the content of this chapter is independent from GLP. Nevertheless, certain topics covered by GLP can be seen as valuable across biomedical research. Examples are focus on transparency and the importance of clear roles and responsibilities for different functions participating in a study.