adminMTE_04792024-02-01T16:59:23+00:00June 5th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Free Webinar|
FREE WEBINAR, JOIN US! WHEN: JUNE 10, 5 PM CET (Milan time) - Italian language Register for free! WHY YOU SHOULD PARTICIPATE: This webinar offers a training opportunity for more than 1000 Italian companies facing the challenge for the [...]
k.janecek2024-02-29T17:18:32+00:00June 5th, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The US Food and Drug Administration (FDA) updates its guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The Agency added information about electronic signatures for informed consent and provided clarification about remote assessments during [...]
adminMTE_04792024-02-29T15:25:55+00:00June 3rd, 2020|Categories: Clinical Trial, Covid-19, UK|Tags: Clinical Trial, Covid-19, UK|
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched Yellow Card, a dedicated site for reporting COVID-19 related adverse medical device incidents and side effects from medicines. You can report on Yellow Card if: a medicine causes side [...]
adminMTE_04792024-02-26T10:55:19+00:00June 2nd, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA|
The U.S. Food and Drug Administration is making its previously developed FDA MyStudies app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or [...]
k.janecek2024-02-29T14:13:21+00:00May 29th, 2020|Categories: Covid-19, Europe, Regulatory, Western Europe|Tags: Covid-19, Regulatory, Spain|
The Spanish Agency of Medicines and Medical Devices (AEMPS) moved to May 25th, 2021 the deadline for changing the labelling and instructions for use of medical devices due to Brexit. This decision aims at allowing manufacturers to face the [...]
adminMTE_04792024-02-26T09:34:50+00:00May 28th, 2020|Categories: Compliance, Regulatory, USA|Tags: Covid-19, FDA, USA|
FDA released recommendations for sponsors of decontamination and bioburden reduction systems about what information should be included in a pre-Emergency Use Authorization (pre-EUA) and/or EUA request to help facilitate FDA’s efficient review of such request. Decontamination and bioburden reduction [...]
adminMTE_04792024-02-02T10:53:33+00:00May 28th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, Europe|
The European Medicine Agency (EMA) encouraged collaboration between EU researchers on high-quality, multi-center observational studies of COVID-19 treatments and vaccines. High-quality observational research of real world data collected during the pandemic can be an important complement to the results [...]
adminMTE_04792024-02-29T13:53:58+00:00May 27th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Netherlands|
The Central Committee on Research Involving Human Subjects (CCMO) published a document with the conditions for the (re)start of studies in clinical research units. The document foresees a step-by-step relaxation of the restrictive measures. This makes it possible to [...]
k.janecek2024-02-26T11:05:15+00:00May 26th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Europe, Italy|
Italy has been the gateway to Europe for the Coronavirus pandemic. The crisis has raised many questions about our vulnerabilities and strengths. After the emergency, what is our future? What is the new reality in the wake of the [...]
adminMTE_04792024-02-07T16:13:06+00:00May 25th, 2020|Categories: Covid-19, Regulatory, USA|Tags: Covid-19, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) published a guidance describing how medical device manufacturers should notify CDRH of shortages during the COVID-19 emergency. This is a new reporting requirement for medical [...]
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