adminMTE_04792024-02-07T16:07:23+00:00April 11th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR|Tags: Clinical Trial, Covid-19, Europe, MDR|
Few changes made and… review by Parliament announced on APRIL 16th! On April 7, 2020 the Presidency of Council of the European Union (EU) examined the European Commission (EC) proposal for MDR delayed application, including the urgent measures regarding devices [...]
k.janecek2024-02-26T11:53:42+00:00April 9th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, Europe|
Today, the international regulators have published a report highlighting their reflections on the development of potential COVID-19 therapies, clinical trials, and compassionate use programs. The report presents the results of a virtual meeting from April 2nd, 2020 on COVID-19 [...]
k.janecek2024-02-02T11:24:14+00:00April 3rd, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, Europe|
EU has updated their COVID-19 clinical trial guidance that was initially released on March 20, 2020. Version 2, published on March 27, includes the following key changes from version 1: Initiating new clinical trials The feasibility of starting a [...]
k.janecek2024-02-26T11:12:52+00:00March 27th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
On March 26, 2020, the BfArM published "Additional recommendations on the European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic " for clinical trials with medicinal products. All recommendations are aimed at: continue to ensure [...]
adminMTE_04792024-02-02T11:39:10+00:00March 26th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, Europe, Helpline|
The European Medicines Agency (EMA) published a new draft guideline for clinical trials inviting sponsors to evaluate the implications of COVID-19 on methodological aspects of ongoing trials. This guidance covers actions that sponsors of ongoing clinical trials affected by [...]
adminMTE_04792024-02-26T16:58:31+00:00March 25th, 2020|Categories: Europe, Innovation, MDR|Tags: Europe, MDR|
Today’s live read-out by the European Commission spokesperson Stefan De Keersmaecker announced a proposal to delay the application of the new MDR. “The European Commission is working on a proposal to postpone the entry into force of the new [...]
adminMTE_04792024-02-02T10:35:12+00:00March 24th, 2020|Categories: Europe, Western Europe|Tags: Clinical Trial, Covid-19, Denmark, Europe, Helpline, Western Europe|
UPDATE ON March 24th, 2020 Danish Medicines Agency (Lægemiddelstyrelsen) issued guidance regarding extraordinary measures and further amendment dated March 24th for clinical trials during a pandemic emergency. The Agency is aware of Covid-19 influence on the conduct of clinical [...]
adminMTE_04792024-02-29T14:29:45+00:00March 21st, 2020|Categories: Europe, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Helpline, Switzerland, Western Europe|
UPDATE ON March 21st, 2020 The Swiss federal government published an ordinance to conduct clinical trials during the COVID-19 emergency. This legislation applies to Sponsors, investigators and project leaders of clinical trials and research projects in Switzerland. It is [...]
adminMTE_04792024-02-07T15:54:29+00:00March 20th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, Europe, Helpline|
This guidance includes a harmonised set of recommendations, to ensure the utmost safety of trial participants across the European Union while preserving the quality of the data generated by the trials. It also advises how these changes should be [...]
adminMTE_04792024-02-29T13:55:20+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Helpline, Netherlands, Western Europe|
The Netherlands’ Central Committee on Research Involving Human Subjects (CCMO) announced the availability of fast-track approval procedures for clinical trials related to the development of vaccines for COVID-19. To make use of this procedure, please contact CCMO via ccmo@ccmo.nl or telephone [...]
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
