Roberto Cioeta, Andrea Cossu, Emiliano Giovagnoni, Marta Rigoni, Paola Muti,
The recent passage of European Union (EU) Regulation 2017/745 on medical devices (MDs) has improved the classification of MDs and revised their approval process and the post-marketing evaluation of their safety and effectiveness, promoting transparency and post-marketing oversight in Europe. This new regulation can better ensure patient safety and provide new opportunities for therapeutic innovation. In addition, the new regulations include and define MDs made of substances or of combinations of substances ( ...
Tópico(s): Pharmaceutical studies and practices
2022 - Frontiers Media | Frontiers in Drug Safety and Regulation
Roberto Cioeta, Paola Muti, Marta Rigoni, Luigi Morlando, Filippo Siragusa, Andrea Cossu, Emiliano Giovagnoni,
Background: Gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) are very common in the general population. GERD prevalence is considerably high in pregnant women, and it increases at a young age, alongside obesity. Mucosal protective agents (MPAs) are over-the-counter (OTC) treatments for FD and GERD commonly used alone or as add-on therapy to proton pump inhibitors (PPIs). Real-world data through surveys allow a clinical evaluation of marketed products that also complies with the new ...
Tópico(s): Gastrointestinal motility and disorders
2022 - Frontiers Media | Frontiers in Drug Safety and Regulation
Roberto Cioeta, Paola Muti, Marta Rigoni, Andrea Cossu, Emiliano Giovagnoni,
Diarrhea continues to be a global health problem as acute diarrhea carries the risk of dehydration, while both acute and chronic diarrhea can significantly affect patients’ quality of life and reduce productivity. The innovative medical device Actitan, which consists of a complex of natural molecules, could be an effective option for the treatment of diarrhea from various causes. The aim of this post-market cross-sectional study was to evaluate the perceived efficacy, safety and usage pattern of ...
Tópico(s): Helicobacter pylori-related gastroenterology studies
2024 - Multidisciplinary Digital Publishing Institute | Gastrointestinal Disorders
Daniela Paula de Lima Nunes Malta, Cleberson Cordeiro de Moura, Francielle Rodrigues Costa Emiliano, Gabriela Clotilde dos Santos Monteiro, Josiane Reis Araújo, Luciana Quintana, Patrícia Pereira de Souza Rigoni, Ziza Silva Pinho Woodcock,
O artigo em pauta, aborda sobre importância da educação inclusiva como um direito fundamental e sua implementação nas políticas educacionais brasileiras, Partindo desse viés a inclusão vai além da simples presença de alunos com necessidades educacionais especiais nas escolas, buscando garantir que todos tenham acesso a uma educação de qualidade que respeite e valorize a diversidade. Apesar dos avanços nas diretrizes, a efetiva aplicação da inclusão ainda enfrenta desafios, como a falta de recursos, ...
Tópico(s): Social and Political Issues
2024 - Servicios Academicos Intercontinentales | OBSERVATÓRIO DE LA ECONOMÍA LATINOAMERICANA