adminMTE_04792024-02-29T17:05:07+00:00June 24th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA published a Q&A document to respond frequently asked questions from submitters and applicants on regulatory matters and issues relating to medical devices arising from the COVID-19 public health emergency. This guidance addresses the following: Meetings with Industry MDUFA [...]
adminMTE_04792024-02-26T09:26:25+00:00June 18th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The FDA issued guidance to provide sponsors with statistical advice in order to maintain trial integrity and reduce the impact of the COVID-19 emergency on clinical trials conduct. This new document follows the agency’s guidances on the conduct of [...]
k.janecek2024-02-29T10:16:35+00:00June 17th, 2020|Categories: Clinical Trial, Compliance, Innovation, Regulatory, Software, Switzerland|Tags: Europe, Expert, Innovation, Regulatory, Switzerland, Venturelab|
Dr. Monica Tocchi, CMO and Founder of Meditrial joined the Innosuisse Start-up Training program designed by Venturelab, as a member of their Expert panel. The panel is composed of successful founders, leading academic and industry partners that bring the [...]
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 [...]
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 [...]
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 [...]
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 [...]
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