This "Implementation Guidance and Guidelines" document, part of the In Silico World project's "Ethical and Legal Framework," offers twelve key recommendations on the ethical and legal aspects of in silico trials.
In silico trials involve the virtual testing of medical devices and medicinal products, aiding the regulatory approval process and supporting the entire lifecycle of medical products. This document, "Implementation Guidance and Guidelines," is part of the "Ethical and Legal Framework" of the In Silico World project, and provides ethical and legal guidelines for researchers and end users involved in In Silico Trials.
This report builds on previous documents, "Legal and Ethical Inventory" and "In-depth Analysis of Legal and Ethical Requirements," which examined key legislation and ethical principles relevant to In Silico Trials. It presents twelve main recommendations across the following areas:
Each area includes concise and descriptive recommendations. Access the full document for detailed information!
