Meditrial Editorial Team2024-02-29T14:17:04+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 [...]
Meditrial Editorial Team2024-02-29T09:53:15+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 [...]
Meditrial Editorial Team2024-02-29T13:50:15+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 [...]
k.janecek2024-02-26T12:08:56+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease. 'The COVID-19 pandemic affects the whole world and the best way to fight it [...]
k.janecek2024-02-02T11:41:53+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, EMA, Europe, European Commission, Regulatory|
European Medicines Agency (EMA) updated the guidance on the management of clinical trials during COVID-19 pandemic. Version 3 published on 28 April 2020 provides additional clarification on: the distribution of medicines to trial participants. This takes into account social-distancing measures [...]
k.janecek2024-02-29T09:43:48+00:00April 28th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, European Union, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for post market clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators. Equivalence [...]
k.janecek2024-02-07T16:09:22+00:00April 28th, 2020|Categories: Covid-19, USA|Tags: Covid-19, FDA, USA|
The FDA developed a fact sheet in collaboration with the Centers for Disease Control and Prevention (CDC) to help answer questions from the food and agriculture sector about what respirators, disposable face masks, such as surgical or medical masks, or [...]
Meditrial Editorial Team2024-02-23T16:59:16+00:00April 27th, 2020|Categories: Compliance, USA|Tags: Covid-19, Digital Health, FDA, USA|
FDA issued guidances to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides and non-invasive fetal and maternal monitoring devices during COVID-19 pandemic. Enforcement Policy for [...]
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