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 [...]
k.janecek2023-03-29T13:55:52+00:00April 22nd, 2022|Categories: Compliance, Europe, Regulatory|Tags: Clinical Trial, Compliance, Pharma, pharmacovigilance, Regulatory|
In 2017, PRAC established a strategy for measuring the impact of pharmacovigilance activities, and EMA has published a second revision in April 2022. The second revision of the PRAC Impact Strategy integrates the achievements over a five-year period since its launch in [...]
Elena Trombettoni2024-02-29T14:33:14+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|
The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device enumerations v2.7 MDR and IVDR introduce an EU device [...]
k.janecek2023-03-29T14:01:39+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|Tags: Compliance, Europe, European Commission, European Union, IVD, IVDR, MDR, Medical Devices, MedTech|
The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device enumerations v2.7 MDR and IVDR introduce an EU device [...]
k.janecek2023-03-29T14:01:43+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: Clinical Trial, Compliance, EMA, Europe, MedTech, Regulatory, Regulatory Affairs|
EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]
k.janecek2023-03-29T14:01:51+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: Clinical Trial, Compliance, EMA, Europe, European Union, medicines, Regulatory, Regulatory Affairs|
The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors [...]
k.janecek2023-03-29T14:01:53+00:00March 24th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: Compliance, eumdr, Europe, European Commission, European Union, MDR, Medical Devices, MedTech, Regulatory, Regulatory Affairs|
The BVMed - German Medical Technology Association and SNITEM - the French National union of the medical technology industry are launching a Franco-German initiative for Medical Device Regulation. In a joint statement, they call for three important points and [...]
k.janecek2023-03-29T14:02:09+00:00March 11th, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: Clinical Trial, Compliance, Europe, medicaldevice, medicaldevices, medicines, Regulatory Affairs, Spain|
The Spanish Data Protection Authority (AEPD) has recently approved the first industry code of conduct (CoC) under the General Data Protection Regulation (GDPR). The CoC has been promoted by Farmaindustria (the National Business Association of the Pharmaceutical Industry) and [...]
k.janecek2024-02-29T14:19:54+00:00March 8th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: Compliance, Europe, Medical Devices, MedTech, Regulatory Affairs, Switzerland|
The Swiss Single Registration Number (CHRN) is assigned by Swissmedic based on the Medical Device Ordinance (MedDO; SR 812.213). It is assigned to Swiss manufacturers, authorised representatives or importers and serves to uniquely identify them. Meditrial successfully represents many [...]
k.janecek2024-02-29T14:19:37+00:00March 4th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: Compliance, Europe, MedTech, Regulatory, Regulatory Affairs, Switzerland|
Swissmedic is in the process of developing a new database for registering economic operators and medical devices. Due to the continuing aim of equivalence between regulation in Switzerland and the EU, the medical devices database will be similar to EUDAMED. [...]
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