adminMTE_04792024-02-02T11:48:58+00:00May 14th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory|Tags: Covid-19, EMA, Europe, Regulatory|
The European Medicines Agency (EMA) updated information on its dedicated task forces to deal with the scientific, regulatory and operational challenges generated by the COVID-19 pandemic and initiated its business continuity plan. The aim of these measures is to [...]
adminMTE_04792024-02-29T14:36:51+00:00May 14th, 2020|Categories: Compliance, Covid-19, Europe, Software|Tags: Covid-19, Digital Health, Europe, European Commission|
The European Commission (EC) shared a Q&A on safe and efficient use of mobile tracing apps across the EU. What is a contact tracing and warning app? A contact tracing and warning app is voluntarily installed and used to [...]
k.janecek2024-02-29T10:35:34+00:00May 11th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Europe|
Today is a special day for the Meditrial family. In Italy, we said goodbye on March 10th and for 62 days, we faced the challenge of smart-working, with complete dedication to overcoming the storm together with our country. We [...]
adminMTE_04792024-02-29T10:32:34+00:00May 9th, 2020|Categories: Europe|Tags: Italy|
Meditrial is ready to reopen the Italian offices. We all tested negative and are happy to be back together safely next Monday! We have been working remotely during the lockdown in Italy, in order to continue to provide support [...]
k.janecek2024-02-29T13:49:11+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, MHRA, Regulatory, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance for industry on their flexible approaches to regulation during the COVID-19 outbreak. MHRA are working closely with the Department of Health and Social Care (DHSC) and other healthcare [...]
adminMTE_04792024-02-29T14:17:04+00:00May 5th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Helpline, Spain, Western Europe|
UPDATED ON May 5th, 2020 The Spanish Agency for Medicines and Health Products (AEMPS) provides recommendations for exceptional application during the period of the COVID-19 crisis in Spain. “It is important that the sponsor together with the investigator make [...]
adminMTE_04792024-02-29T09:53:15+00:00May 4th, 2020|Categories: Europe|
Meditrial is happy to announce the reopening of our Berlin Office as of today, May 4th. We have been working remotely during the lockdown in Germany, in order to continue to provide support and services to our customers all [...]
k.janecek2024-02-29T13:59:58+00:00May 1st, 2020|Categories: Covid-19, Europe, USA|Tags: Covid-19, Europe, Helpline, USA|
By Dr. Monica Tocchi, MD, PhD One million Covid-19 patients have returned to their homes after discharge from hospital. But are they fully healed? Why is this not being discussed amidst the crisis? It is a burning global health [...]
k.janecek2024-02-29T14:08:24+00:00April 30th, 2020|Categories: Covid-19, Europe, Regulatory, USA|Tags: Covid-19, Europe, Regulatory, USA|
Both the European and the United States regulatory authorities have issued multiple guidances in response to the COVID-19 emergency, in order to ease the burden on the healthcare system and facilitate the production and import of needed devices during [...]
adminMTE_04792024-02-29T13:50:15+00:00April 30th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory, UK|Tags: Covid-19, Europe, Regulatory, UK|
MHRA updated the guidance on the clinical requirements to consider for ventilators during COVID-19 emergency. This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and [...]
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