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 [...]
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_04792024-02-29T17:19:53+00:00March 23rd, 2020|Categories: Clinical Trial, Covid-19|Tags: Clinical Trial, Covid-19, Helpline|
The Jack Ma Foundation and Alibaba Foundation have convened a group of medical experts who have just returned from the frontlines of fighting the pandemic in China. With the support of the First Affiliated Hospital, Zhejiang University School of [...]
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