k.janecek2024-02-29T15:17:32+00:00May 22nd, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, MHRA, Regulatory, UK|
On 21 May 2020, NIHR set out a framework to guide the restarting of NIHR research activities which have been paused due to COVID-19. Sponsors planning to restart trials or to initiate new clinical trials should take account of the principles [...]
k.janecek2024-02-26T11:08:52+00:00May 22nd, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: BfArM, Clinical Trial, Covid-19, Germany, Regulatory, Western Europe|
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) and PEI (Paul-Ehrlich-Institut) provided supplementary recommendations to the guideline on management of clinical trials during COVID-19 released by the European authorities on 20th March 2020. Key points of BfArM and PEI recommendations on [...]
adminMTE_04792024-02-26T11:15:21+00:00May 20th, 2020|Categories: Europe, Regulatory, Western Europe|Tags: BfArM, Clinical Trial, DIMDI, Europe, Germany, Regulatory, Western Europe|
DIMDI (Deutsche Institut für Medizinische Dokumentation und Information) and BfArM (Federal Institute for Drugs and Medical Devices) will join to become one agency on May 26th, 2020. Once DIMDI is merged into BfArM, the name that has been in [...]
adminMTE_04792024-02-29T16:29:24+00:00May 20th, 2020|Categories: Compliance, Covid-19, UK|Tags: Covid-19, MHRA, Regulatory, UK|
MHRA issued update to regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment). Contents Antimicrobial hand sanitisers and gels Face masks Gloves Offers to supply or donate healthcare equipment to the NHS/healthcare providers [...]
adminMTE_04792024-02-02T11:50:42+00:00May 19th, 2020|Categories: Covid-19, Europe, Regulatory|Tags: Covid-19, EMA, Europe, Regulatory|
The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic [...]
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_04792024-02-02T11:48:58+00:00May 14th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory|Tags: Covid-19, EMA, Europe, Regulatory|
The European Medicines Agency (EMA) updated information on its dedicated task forces to deal with the scientific, regulatory and operational challenges generated by the COVID-19 pandemic and initiated its business continuity plan. The aim of these measures is to [...]
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.janecek2024-02-29T14:08:24+00:00April 30th, 2020|Categories: Covid-19, Europe, Regulatory, USA|Tags: Covid-19, Europe, Regulatory, USA|
Both the European and the United States regulatory authorities have issued multiple guidances in response to the COVID-19 emergency, in order to ease the burden on the healthcare system and facilitate the production and import of needed devices during [...]
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