k.janecek2023-03-29T14:01:43+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: Clinical Trial, Compliance, EMA, Europe, MedTech, Regulatory, Regulatory Affairs|
EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]
k.janecek2024-02-02T10:24:34+00:00June 30th, 2020|Categories: Clinical Trial, Covid-19, Eastern Europe, Europe, Regulatory|Tags: Clinical Trial, Covid-19, Czech Republic, Regulatory|
The Czech Authority State Institute for Drug Control (SÚKL) updated its general recommendations respecting the current epidemiological situation with coronavirus regarding ongoing or not yet started clinical trials and the release of emergency measures of the government. This opinion [...]
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_04792024-02-29T14:10:08+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_04792024-02-29T14:01:20+00:00March 19th, 2020|Categories: Eastern Europe, Europe|Tags: Clinical Trial, Covid-19, Eastern Europe, Helpline, Poland|
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland issued guidelines on clinical research under COVID-19. Inspections activity of clinical trial is suspended until the end of April 2020. The decision to resume the [...]
adminMTE_04792024-02-29T14:11:03+00:00March 19th, 2020|Categories: Eastern Europe, Europe|Tags: Clinical Trial, Covid-19, Eastern Europe, Helpline, Slovakia|
The State Institute for Drug Control (SUKL) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Slovakia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice [...]
adminMTE_04792024-02-02T11:56:18+00:00March 18th, 2020|Categories: Eastern Europe, Europe|Tags: Clinical Trial, Covid-19, Eastern Europe, Estonia, Helpline|
The State Agency of Medicines issued a guideline on clinical trial management which is in effect until the end of the Emergency Situation, which was declared by the Government of Estonia until 1 May 2020. Meditrial manages several studies [...]
adminMTE_04792024-02-26T16:07:57+00:00March 17th, 2020|Categories: Eastern Europe, Europe|Tags: Clinical Trial, Covid-19, Eastern Europe, Helpline, Latvia|
State Agency of Medicines (SAM) of Republic of Latvia issued guidelines on clinical research under COVID-19. Meditrial manages several studies in Latvia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for [...]
adminMTE_04792024-02-02T10:16:28+00:00March 16th, 2020|Categories: Eastern Europe, Europe|Tags: Clinical Trial, Covid-19, Czech Republic, Eastern Europe, Europe, Helpline|
The Czech Authority State Institute for Drug Control (SÚKL) has issued an opinion on a clinical research under current COVID-19 pandemic on 13 March and provided additional clarifications regarding the management of patients visits and study products on 16 [...]
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