Volume 39, no. 6, September 2026. The value of monitoring registers for advanced therapy medicinal products. ImmunoMania 2.0: a science communication approach through game-based learning methodologies. The National Institute of Health in Italy − ISS whistleblowing reporting platform as a model of public integrity. RarISS Insert. Lucio Anneo Seneca
Volume 39, no. 6, September 2026. The value of monitoring registers for advanced therapy medicinal products. ImmunoMania 2.0: a science communication approach through game-based learning methodologies. The National Institute of Health in Italy − ISS whistleblowing reporting platform as a model of public integrity. RarISS Insert. Lucio Anneo Seneca
Abstracts:
The value of monitoring registers for advanced therapy medicinal products
Advanced therapies are transforming the prognosis of many diseases for which there are no other therapeutic options, but they require careful long-term monitoring. In Italy, the Istituto Superiore di Sanità (National Institute of Health in Italy) collects and monitors information on patients enrolled in clinical trials in a national database since 2004 and, since 2015, in an internal database on patients treated under Hospital Exemption (HE). Two monitoring registries were established in 2017 (PMDC of 3 March 2017) and, since 2024, these have been integrated into a web-based IT platform. This allows for more efficient follow-up and the standardisation of functional safety and efficacy parameters, which are essential for consolidating knowledge over time of the effects linked to the innovative nature of advanced therapies.
ImmunoMania 2.0: a science communication approach through game-based learning methodologies
During the 2025 European Researchers’ Night and within the school activities of Rome’s Educating City Map 2024-2025, the Istituto Superiore di Sanità (National Institute of Health in Italy, ISS) presented a new edition of ImmunoMania, an educational kit designed to introduce young people to immunology through play. Updated and expanded in collaboration with ISIA Roma Design (Istituto Superiore per le Industrie Artistiche), the kit includes science-themed board games, interactive laboratories, posters, and renewed informational materials in both content and graphics. Students explored the immune system in a simple, engaging way, confirming the effectiveness of playful, participatory science communication in fostering learning, dialogue, curiosity, and involvement.
The National Institute of Health in Italy − ISS whistleblowing reporting platform as a model of public integrity
The legal transposition of Directive (EU) 2019/1937 has initiated a structural metamorphosis in corruption prevention systems, establishing whistleblower confidentiality as an unavoidable technical pre-requisite for the exercise of the duty to report unlawful conduct or irregularities within one's work context, proper to every public employee (see Presidential Decree 62/2013, updated by Presidential Decree 81/2023). This paper examines the technological infrastructure implemented by the Istituto Superiore di Sanità (National Institute of Health in Italy, ISS), based on the GlobaLeaks framework, analyzing its cryptographic protocols, network anonymization systems, and rigorous document security procedures.
