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 [...]
Meditrial Editorial Team2024-02-29T15:21:59+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 [...]
Meditrial Editorial Team2024-02-29T15:25:55+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 [...]
Meditrial Editorial Team2024-02-26T10:55:19+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 [...]
Meditrial Editorial Team2024-02-26T09:34:50+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 [...]
Meditrial Editorial Team2024-02-02T10:53:33+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 [...]
Meditrial Editorial Team2024-02-29T13:53:58+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.janecek2024-02-01T14:12:57+00:00May 27th, 2020|Categories: Europe, Innovation, Switzerland|Tags: Innovation, Switzerland|
On 4th June 2020, Dr. Monica Tocchi, Founder and CMO of Meditrial will hold a virtual training hosted by Venturelab – a swiss startup training program commissioned by Innosuisse . This intensive course entitled “Win KOLs and work with partners” is [...]
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