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 [...]
adminMTE_04792024-02-26T12:26:55+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 [...]
adminMTE_04792024-02-26T09:43:11+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. [...]
adminMTE_04792024-02-26T09:44:34+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 [...]
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 [...]
k.janecek2024-02-29T15:19:51+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on Medical devices clinical investigations during the COVID-19 outbreak. The guidance was first published on March 30th, 2020. In the last update of May 7th, a new section on [...]
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 [...]
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