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 [...]
e.alvarado2022-07-06T15:23:20+00:00June 8th, 2022|Categories: Meditrial|Tags: Clinical Trial, DECENTRALIZED TRAILS, EDC, Medical Devices, Patient, PRO|
Research and innovation are based on rigorous clinical trials involving patients firsthand. The main actor in clinical trials is the patient affected by the disease under examination. Including the patient’s perspective allows us to reduce barriers that otherwise limit your [...]
e.alvarado2022-07-05T08:43:00+00:00June 1st, 2022|Categories: Meditrial|Tags: Authorized European Representative, Authorized Representative, Device Vigilance, Incident, MDV, MEDICAL DEVICE VIGILANCE, Medical Devices, UNDERREPORTING|
Italy has recently instituted substantial changes in national regulations on medical device vigilance in order to align our procedures with European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics. As of Oct. 16, 2022, the new rules [...]
Elena Trombettoni2022-07-04T15:48:41+00:00June 1st, 2022|Categories: AboutPharma|
L’Italia ha recentemente istituito cambiamenti sostanziali nella normativa nazionale in materia di vigilanza sui dispositivi medici al fine di allineare le nostre procedure con i Regolamenti europei 2017/475 per i dispositivi medici e 2017/476 per i diagnostici in [...]
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