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 [...]
Meditrial Editorial Team2022-07-05T13:27:04+00:00May 25th, 2022|Categories: AboutPharma|
La sfida di reclutare i pazienti adatti negli studi clinici ha da sempre rappresentato un ostacolo significativo ai programmi di sviluppo dei farmaci e dispositivi medici. La difficoltà di generare evidenze ritarda l'introduzione di nuovi interventi medici [...]
Meditrial Editorial Team2022-07-05T13:35:47+00:00May 17th, 2022|Categories: AboutPharma|
Nel corso di due anni di pandemia, si sono susseguiti accesi dibattiti sulla sicurezza ed efficacia dei vaccini anti-Covid-19. Ancora oggi, dopo oltre 7 miliardi di dosi somministrate, continuano ad emergere problematiche sulle evidenze cliniche disponibili (Il Tempo). [...]
Meditrial Editorial Team2022-07-05T13:35:56+00:00May 11th, 2022|Categories: AboutPharma|
Paola Antonini, Direttore Scientifico Meditrial. Complici la pandemia e le informazioni condivise sui social media, l’accresciuta attenzione degli individui alla propria salute e benessere ha portato ad un notevole aumento dei consumi di integratori alimentari come [...]
Meditrial Editorial Team2022-07-05T08:53:13+00:00May 4th, 2022|Categories: AboutPharma|
Nasce su AboutPharma Online, in Collaborazione con Meditrial, uno spazio per illustrare le nuove roadmap per lo sviluppo clinico e come prepararsi. Lo sviluppo clinico è un termine tradizionalmente utilizzato per definire l'intero processo di immissione sul [...]
Meditrial Editorial Team2023-03-29T14:46:55+00:00January 28th, 2022|Categories: Uncategorized|Tags: Conformity Assessment, EU IVDR, Invitro Diagnostics, MedTech, Post Market Surveillance, Regulatory Affairs|
New #MDCG Guidance on general principles for #clinicalevidence and the continuous process of performance evaluation for #IVDs has been published The guidance describes the approach by which collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing [...]
Meditrial Editorial Team2023-03-29T14:47:07+00:00January 12th, 2022|Categories: Compliance, Covid-19, Europe, Regulatory|Tags: Compliance, Covid-19, Europe, Invitro diagnostic devices|
The MDCG 2022-1 Notice has been published It is addressed to manufacturers of SARS-CoV-2 IVDs based in a third country and who place or intend to place their in vitro diagnostics on the EU market. It highlights a number of common issues [...]
Meditrial Editorial Team2023-03-29T14:47:59+00:00January 3rd, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: Compliance, ctis, EMA, Regulatory Affairs, regulatorycompliance, SAFETY|
European Medicines Agency published a new Guideline on the reporting of Serious Breaches, that will come into effect on January 31, 2022. Find out: ✔ how to report serious breach ✔ responsibilities of the different parties involved in the notification ✔ examples [...]
Meditrial Editorial Team2023-03-29T15:48:06+00:00January 3rd, 2022|Categories: Compliance, Regulatory|Tags: Compliance, eumdr, IVDR, Regulatory Affairs|
The European Commission has updated the Eudamed Actor Module FAQs. The document includes a revision of paragraph 4.6.4 relating to the publicly accessible contact details of Person Responsible for Regulatory Compliance (PRRC). Read more in the EC document. Contact Meditrial [...]
Meditrial Editorial Team2023-03-29T15:49:01+00:00December 1st, 2021|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: Clinical Investigation, Clinical Trial, eumdr, Europe, European Union, MDCG, Medical Devices|
New guideline for Europe on trial changes has been published! MDCG 2021-28 - Substantial modification of clinical investigation under Medical Device Regulation. The sponsor of a clinical investigation is required to submit an application to the Member State in [...]
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