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_04792024-02-02T10:35:12+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 [...]
adminMTE_04792024-02-26T12:16:42+00:00March 23rd, 2020|Categories: Europe, Western Europe|Tags: Clinical Trial, Covid-19, Ireland, Western Europe|
Health Product Regulatory Authority (HPRA) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Ireland and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support. [...]
adminMTE_04792024-02-26T15:59:57+00:00March 23rd, 2020|Categories: Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Helpline, Italy, Western Europe|
A slowdown of the rising trends in the number of Covid infections and deaths was recorded today by the Italian Civil Protection. Healthcare workers infected rise to 4,824 and now their testing is prioritized. The total lockdown in Italy [...]
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 [...]
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 [...]
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