Good Practices are consensus documents produced by a group of experts – organised in a formal or informal Community of Practice – in order to capture salient aspects of performing a specific activity in the way that the group considers the best possible.
Following the experience accumulated around important documents such as the Good Clinical Practice, the Good Manufacturing Practice, or the Good Laboratory Practice, a group of experts coordinated by the Avicenna Alliance and the VPH Institute is developing the first proposal for Good Simulation Practice (GSP).
A first step toward the compilation of the GSP is to collect all regulatory documents of the various authorities around the world that are related to this topic.
- IMDRF, 2014 – “Software as a Medical Device”: Possible Framework for Risk Categorization and Corresponding Considerations (.docx)
- EMA, 2016 – Workshop. Workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation
- FDA, 2016 – Guideline. Reporting of Computational Modeling Studies in Medical Device Submissions
- EMA, 2017 – Guideline. Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation.
- ASME, 2018 – Technical Standard VV-40 2018 – Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices
- University of Bath, 2018 – Clinical Trial validation. ToKa HTO Versus Generic HTO Virtual Clinical Trial
- FDA, 2018 – Presentation. How Simulation Can Transform Regulatory Pathways
- FDA, 2018 – Pilot Program. Model-Informed Drug Development Pilot Program
- FDA, 2019 – Guidance Document. Clinical Decision Support Software
- EMA, 2019 – Presentation. Optimise capabilities in modelling, simulation and extrapolation
- European Commission, 2020 – Guideline. MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- IMDRF, 2017 – Software as a Medical Device (SaDM): Clinical Evaluation (.docx)
- IMDRF, 2018 – Optimizing Standards for Regulatory Use (.docx)
- IMDRF, 2019 – Guideline. Guidance on Clinical Evaluation (.docx)
- IMDRF, 2019 – Guideline. Clinical Evidence – Key Definitions and Concepts (.docx)
- IMDRF, 2019 – Guideline. Clinical Investigation (.docx)