k.janecek2024-02-07T16:16:06+00:00May 18th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA issued a guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 emergency. FDA [...]
adminMTE_04792024-02-26T16:45:36+00:00May 15th, 2020|Categories: Clinical Trial, Compliance, MDR, Regulatory|Tags: Clinical Trial, Europe, MDCG|
The European Commission’s Medical Device Coordination Group (MDCG) issued a guidance explaining how safety reporting in clinical investigations of medical devices should be performed under the MDR. The guidance applies to: premarket clinical investigations of non-CE marked devices, premarket [...]
adminMTE_04792024-02-26T12:26:55+00:00May 13th, 2020|Categories: Clinical Trial, Covid-19, Israel|Tags: Clinical Trial, Covid-19, Israel|
Good news from Israel! Our monitors informed us about the restart of onsite monitoring visits after the break imposed by the COVID-19 emergency. Monitoring visits will be conducted in compliance with safety rules. Meditrial is closely monitoring the situation [...]
adminMTE_04792024-02-26T09:43:11+00:00May 13th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
FDA published the guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice(GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. [...]
adminMTE_04792024-02-26T09:44:34+00:00May 13th, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
The FDA is collaborating with the CDC to develop a process that would govern how and where to return to on-site facility surveillance inspections in accordance with the gating criteria outlined in the White House Guidelines for Opening Up [...]
k.janecek2024-02-29T13:49:11+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, MHRA, Regulatory, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance for industry on their flexible approaches to regulation during the COVID-19 outbreak. MHRA are working closely with the Department of Health and Social Care (DHSC) and other healthcare [...]
k.janecek2024-02-29T15:19:51+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on Medical devices clinical investigations during the COVID-19 outbreak. The guidance was first published on March 30th, 2020. In the last update of May 7th, a new section on [...]
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.janecek2024-02-26T12:08:56+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease. 'The COVID-19 pandemic affects the whole world and the best way to fight it [...]
k.janecek2024-02-02T11:41:53+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, EMA, Europe, European Commission, Regulatory|
European Medicines Agency (EMA) updated the guidance on the management of clinical trials during COVID-19 pandemic. Version 3 published on 28 April 2020 provides additional clarification on: the distribution of medicines to trial participants. This takes into account social-distancing measures [...]
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