adminMTE_04792024-02-26T17:00:11+00:00April 6th, 2020|Categories: Clinical Trial, Covid-19, Europe|
In response to the Covid-19 emergency, the European Commission released a proposal to amend certain provisions of the Medical Device Regulation (EU) 2017/745. Find out quickly what changes will be made if the proposal is approved by the European [...]
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 [...]
adminMTE_04792024-02-01T16:57:35+00:00April 1st, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Covid-19|
Researchers at Imperial College in London published findings in a study demonstrating up to 120,000 deaths may have already been averted in 11 countries, including the UK, Italy and Spain. Moreover, they add that the estimated proportion of people [...]
adminMTE_04792024-02-29T16:35:19+00:00March 31st, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, Helpline, USA|
While global markets are being impacted by COVID-19 pandemic, FDA issues various statements regarding measures to tackle the negative impact on industry and people. Following, we provide a summary of FDA recently introduced regulatory policies. March 31 The FDA [...]
adminMTE_04792024-02-01T16:54:53+00:00March 30th, 2020|Categories: Clinical Trial, Compliance, Covid-19|Tags: Clinical Trial, Covid-19|
PROTOCOL AMENDMENT: The submission of amendments and related documents, must be presented to MoH -INVIMA-, including the approval letter of at least one Research Ethics Committee. INVIMA will evaluate and issue a concept for these documents and provide 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_04792024-02-26T11:39:00+00:00March 25th, 2020|Categories: Eastern Europe, Europe|Tags: Clinical Trial, Covid-19, Eastern Europe, Helpline, Hungary|
UPDATE ON MARCH 25th, 2020 OGYEI National Institute of Pharmacy and Nutrition updated special measures to face COVID-19 emergency. Updated instructions concern among others: Authorization procedure for new study applications or amendments: sponsors should submit as "urgent safety measure" [...]
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_04792024-02-01T16:16:31+00:00March 25th, 2020|Categories: Europe, Western Europe|Tags: Belgium, Clinical Trial, Covid-19, Helpline, Western Europe|
UPDATE ON March 25th, 2020 Federal Agency for Medicine and Health Products (FAMHP) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Belgium and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel [...]
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