adminMTE_04792024-02-29T14:18:56+00:00June 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Spain|
Good news from Spain! Our monitors informed us about the restart of onsite monitoring visits as of today June 8th, 2020 after the break imposed by the COVID-19 emergency. Meditrial is closely monitoring the situation in all countries to restart [...]
adminMTE_04792024-02-29T16:23:25+00:00June 8th, 2020|Categories: Covid-19, Regulatory, UK|Tags: Covid-19, Digital Health, UK|
MHRA provided advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic. Standalone software and apps that meet the definition of a medical device are required to be CE [...]
k.janecek2024-02-29T16:31:53+00:00June 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, UK|Tags: Clinical Trial, Covid-19, Regulatory, UK|
The MHRA updated its Guidance for industry on flexible approaches to regulation they are taking during the COVID-19 outbreak. In the last update from 5th June 2020, the Agency added information on audits of Notified Bodies and manufacturers in [...]
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_04792024-02-29T15:21:59+00:00June 5th, 2020|Categories: Clinical Trial, Covid-19, UK|
The MHRA issued a guidance on the 3D printing of medical devices or component parts during COVID-19. The requirements manufacturers need to meet when 3D printing will depend on whether the item is a medical device, or a piece [...]
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.janecek2024-02-29T13:51:45+00:00June 2nd, 2020|Categories: Europe, Regulatory, Western Europe|Tags: Clinical Trial, Germany, Regulatory|
*** Deutsche Sprache unten *** MPG Basic Course for Investigators, Deputies and Members of the Clinical Study Group - NEW at the Meditrial Academy Berlin The MPG basic course based on the recommendations of the German Federal Medical Association [...]
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 [...]
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