Meditrial Editorial Team2024-02-02T11:48:58+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 [...]
Meditrial Editorial Team2024-02-29T14:36:51+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 [...]
Meditrial Editorial Team2024-02-26T12:26:55+00:00May 13th, 2020|Categories: Clinical Trial, Covid-19, Israel|Tags: Clinical Trial, Covid-19, Israel|
Good news from Israel! Our monitors informed us about the restart of onsite monitoring visits after the break imposed by the COVID-19 emergency. Monitoring visits will be conducted in compliance with safety rules. Meditrial is closely monitoring the situation [...]
Meditrial Editorial Team2024-02-26T09:43:11+00:00May 13th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
FDA published the guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice(GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. [...]
Meditrial Editorial Team2024-02-26T09:44:34+00:00May 13th, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
The FDA is collaborating with the CDC to develop a process that would govern how and where to return to on-site facility surveillance inspections in accordance with the gating criteria outlined in the White House Guidelines for Opening Up [...]
Meditrial Editorial Team2024-02-29T10:32:34+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 [...]
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 [...]
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 [...]
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 [...]
Become part of Meditrial! Subscribe to our newsletter.
Meditrial Europe - VAT CHE-115.033.718 © 2009 - 2026 | All Rights Reserved | Privacy | Terms of Use | Advertising Policy
