adminMTE_04792024-02-29T14:17:04+00:00May 5th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Helpline, Spain, Western Europe|
UPDATED ON May 5th, 2020 The Spanish Agency for Medicines and Health Products (AEMPS) provides recommendations for exceptional application during the period of the COVID-19 crisis in Spain. “It is important that the sponsor together with the investigator make [...]
k.janecek2024-02-29T13:59:58+00:00May 1st, 2020|Categories: Covid-19, Europe, USA|Tags: Covid-19, Europe, Helpline, USA|
By Dr. Monica Tocchi, MD, PhD One million Covid-19 patients have returned to their homes after discharge from hospital. But are they fully healed? Why is this not being discussed amidst the crisis? It is a burning global health [...]
adminMTE_04792024-02-29T16:18:52+00:00April 22nd, 2020|Categories: Covid-19, UK|Tags: Clinical Trial, Covid-19, Helpline, UK|
UPDATED ON April 22nd, 2020 In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on the management of clinical trials in response to the COVID-19 pandemic. "The MHRA will be as flexible and pragmatic as [...]
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_04792024-02-02T11:39:10+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_04792024-02-01T16:16:31+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 [...]
adminMTE_04792024-02-26T16:10:55+00:00March 23rd, 2020|Categories: Eastern Europe, Europe|Tags: Clinical Trial, Covid-19, Eastern Europe, Helpline, Lithuania|
UPDATE ON March 23, 2020 Lithuanian Bioethics Committee issued guidelines on clinical research under COVID-19. However, further guidance is expected to be soon released by the State Medicines Control Agency under the Ministry of Health of the Republic of [...]
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