adminMTE_04792024-02-26T09:10:23+00:00May 25th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) issued a guidance with immediate effect which allows medical device manufacturers to make “limited modifications” to their devices without submitting a premarket approval (PMA), humanitarian device exemption (HDE) supplement or a 30-day [...]
adminMTE_04792024-02-29T14:38:43+00:00May 22nd, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Clinical Trial, Covid-19, Europe, European Commission, Regulatory|
The European Commission issued new regulations simplifying the process for renewing notified body designations prior to the postponed deadline for application of the Medical Devices Regulations (MDR), 26 May 2021. Moreover, the Commission issued guidelines explaining the process and requirements [...]
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_04792024-02-29T16:29:24+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 [...]
adminMTE_04792024-02-01T15:08:04+00:00May 19th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Austria, Clinical Trial, Covid-19, Europe|
The Austrian Federal Office for Safety in Health Care (BASG) updated its FAQ with new information related to the communication with the Federal Office and the withdrawal of measures at the end of the COVID-19 pandemic. Communication with the [...]
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 [...]
k.janecek2024-02-29T13:47:50+00:00May 18th, 2020|Categories: Covid-19, Switzerland|Tags: Covid-19, Europe, Innovation, Switzerland|
Meditrial is happy to announce the reopening of our Swiss Office as of today, May 18th. We have been working remotely during the last two months, in order to continue to provide support and services to our customers all [...]
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 [...]
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