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 [...]
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_04792024-02-29T14:10:08+00:00March 24th, 2020|Categories: Eastern Europe, Europe|Tags: Clinical Trial, Covid-19, Eastern Europe, Helpline, Romania|
UPDATED on March 24th, 2020 National Agency for Medicines and Medical Devices in Romania (ANMDMR) issued an important message to the Sponsors of clinical studies in the country. Announcement from March 13th, 2020 in the local language can be [...]
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