e.alvarado2022-08-04T14:05:47+00:00July 6th, 2022|Categories: Meditrial|Tags: Clinical Trial, Estimand, ICH, PRO, Study Planning|
Edited by Dr. Monica Tocchi, Meditrial medical director. The organization called ICH (International council for harmonization of technical requirements for pharmaceuticals for human use) is a global organization that unites regulatory authorities and the pharmaceutical industry in the common [...]
Meditrial Editorial Team2022-08-04T14:07:45+00:00July 6th, 2022|Categories: AboutPharma|
A cura di Dr. Monica Tocchi, direttore medico Meditrial. L’organizzazione chiamata ICH (International council for harmonisation of technical requirements for pharmaceuticals for human use) è un’organizzazione globale che unisce le autorità regolatorie e l’industria farmaceutica nell’obiettivo comune di [...]
e.alvarado2022-08-04T14:21:10+00:00June 28th, 2022|Categories: Meditrial|Tags: Clinical Trial, Devices, GCP, Good Clinical Practice, IN-VITRO, IVD, IVDR, Medical Devices|
Atty. Alessia Nuciari, director of compliance Meditrial. The in vitro diagnostics industry has undergone a substantial transformation. IVDR Regulation 746/2017, published in May 2017 and applied from May 26, 2022, introduced major changes in the industry. The main [...]
Meditrial Editorial Team2022-08-04T14:11:33+00:00June 28th, 2022|Categories: AboutPharma|
Avv. Alessia Nuciari, direttore responsabile Compliance Meditrial. L'industria della diagnostica in vitro ha subito una trasformazione sostanziale. Il Regolamento IVDR 746/2017, pubblicato a maggio del 2017 e applicato dal 26 maggio 2022, ha introdotto importanti cambiamenti [...]
e.alvarado2022-07-05T13:35:21+00:00June 22nd, 2022|Categories: AboutPharma|
Dr. Kristin Forssmann, direttore sviluppo clinico Meditrial. Dopo oltre 20 anni, è entrata in vigore in Europa una nuova legislazione, il “regolamento sui dispositivi medici” (EU‐MDR 2017/745). I fattori scatenanti l’avvio e l’attuazione di questa legge europea, [...]
e.alvarado2022-07-05T08:28:58+00:00June 22nd, 2022|Categories: Meditrial|Tags: CLINICAL PRACTICE, Devices, EDC, EU-MDR 2017/745, MDR, Medical Devices, PMCF, PMS, Post-market clinical follow-up, Post-market surveillance, Postmarketing, Surveillance|
After more than 20 years, new legislation, the "Medical Device Regulation" (EU-MDR 2017/745), has come into force in Europe. The triggers for the initiation and implementation of this European law, which is much stricter than previous directives, were scandals related [...]
e.alvarado2022-07-05T13:38:23+00:00June 15th, 2022|Categories: Meditrial|Tags: Clinical Trial, Medical Devices, OBSERVATIONAL STUDIES, REAL WORLD EVIDENCE, RWE|
Dr. Paola Antonini, Meditrial scientific director. If well designed, observational studies and registries produce treatment effect data comparable in importance to those in randomized controlled trials,[1] generating information missing in traditional interventional studies and real-world data to support marketing [...]
Meditrial Editorial Team2022-07-05T13:35:30+00:00June 15th, 2022|Categories: AboutPharma|
Dr. Paola Antonini, direttore scientifico Meditrial. Se ben progettati, studi osservazionali e registri producono dati sull'effetto del trattamento paragonabili per importanza a quelli degli studi randomizzati controllati[1] , generando informazioni mancanti negli studi interventistici tradizionali e dati [...]
Meditrial Editorial Team2022-07-05T08:13:01+00:00June 13th, 2022|Categories: MedTech News|
Join Vicki Bebeau, renowned clinical strategist and industry expert, to talk about what to expect and how to prepare. Jim Harmon, US reimbursement specialist, will join the panel, to address the key topic of US reimbursement [...]
e.alvarado2022-07-05T08:11:08+00:00June 8th, 2022|Categories: AboutPharma|
La ricerca e l'innovazione si basano su rigorosi studi clinici che coinvolgono in prima persona i pazienti. L'attore principale degli studi clinici è il paziente affetto dalla malattia in esame. Includere il punto di vista del paziente [...]
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