SophIQ · La Scienza a portata di libro
Il faro regolatorio della Scienza
Normative per orientarsi nella ricerca clinica
Book available in Italian onlyIl faro regolatorio della Scienza is a guide for anyone who wants to navigate clinical research without getting lost in regulatory complexity.
Whether you work as a CRA, Study Coordinator, Data Manager, Clinical Project Manager, site professional or Ethics Committee member—or you are just entering the clinical-trial field—the book takes you through the Italian and European regulatory landscape in clear, professional and practical language.
From essential terminology to observational studies, interventional drug trials and non-commercial research, and from medical devices and in vitro diagnostics to safety and quality, the book provides a reasoned map of the rules that matter in clinical research today.
Rather than offering a sterile list of legal provisions, it focuses on what professionals actually need to understand: how to read a requirement, how the regulatory framework is evolving and how to translate rules into practice.
Inside the book
What you will find
- Italian and European clinical-research regulatory landscape
- Observational studies and interventional medicinal-product trials
- Non-commercial research, medical devices and in vitro diagnostics
- Safety, quality and a reasoned approach to interpreting regulatory requirements
Who it is for
Designed to turn concepts into practice.
For CRAs, Study Coordinators, Data Managers, Clinical Project Managers, site professionals, Ethics Committee members and anyone approaching clinical research for the first time.
Like the other SophIQ titles, the book uses professional yet accessible language, with the aim of connecting theory, regulatory requirements and day-to-day practice.