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 [...]
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.janecek2024-02-01T14:12:57+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 [...]
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 [...]
adminMTE_04792024-02-26T09:10:23+00:00May 25th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) issued a guidance with immediate effect which allows medical device manufacturers to make “limited modifications” to their devices without submitting a premarket approval (PMA), humanitarian device exemption (HDE) supplement or a 30-day [...]
adminMTE_04792024-02-29T14:38:43+00:00May 22nd, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Clinical Trial, Covid-19, Europe, European Commission, Regulatory|
The European Commission issued new regulations simplifying the process for renewing notified body designations prior to the postponed deadline for application of the Medical Devices Regulations (MDR), 26 May 2021. Moreover, the Commission issued guidelines explaining the process and requirements [...]
Become part of Meditrial! Subscribe to our newsletter.
Meditrial Europe - VAT CHE-115.033.718 © 2009 - 2024 | All Rights Reserved | Privacy | Terms of Use | Advertising Policy
