k.janecek2024-02-07T15:50:33+00:00June 9th, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, Regulatory|
The European Commission updated its “rolling plan” for adopting implementing acts and other actions/initiatives ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The update follows the delay of implementation of the MDR by one [...]
k.janecek2024-02-29T16:31:53+00:00June 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, UK|Tags: Clinical Trial, Covid-19, Regulatory, UK|
The MHRA updated its Guidance for industry on flexible approaches to regulation they are taking during the COVID-19 outbreak. In the last update from 5th June 2020, the Agency added information on audits of Notified Bodies and manufacturers in [...]
k.janecek2024-02-29T17:18:32+00:00June 5th, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The US Food and Drug Administration (FDA) updates its guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The Agency added information about electronic signatures for informed consent and provided clarification about remote assessments during [...]
k.janecek2024-02-29T13:51:45+00:00June 2nd, 2020|Categories: Europe, Regulatory, Western Europe|Tags: Clinical Trial, Germany, Regulatory|
*** Deutsche Sprache unten *** MPG Basic Course for Investigators, Deputies and Members of the Clinical Study Group - NEW at the Meditrial Academy Berlin The MPG basic course based on the recommendations of the German Federal Medical Association [...]
k.janecek2024-02-29T14:13:21+00:00May 29th, 2020|Categories: Covid-19, Europe, Regulatory, Western Europe|Tags: Covid-19, Regulatory, Spain|
The Spanish Agency of Medicines and Medical Devices (AEMPS) moved to May 25th, 2021 the deadline for changing the labelling and instructions for use of medical devices due to Brexit. This decision aims at allowing manufacturers to face the [...]
k.janecek2024-02-01T14:12:57+00:00May 27th, 2020|Categories: Europe, Innovation, Switzerland|Tags: Innovation, Switzerland|
On 4th June 2020, Dr. Monica Tocchi, Founder and CMO of Meditrial will hold a virtual training hosted by Venturelab – a swiss startup training program commissioned by Innosuisse . This intensive course entitled “Win KOLs and work with partners” is [...]
k.janecek2024-02-26T11:05:15+00:00May 26th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Europe, Italy|
Italy has been the gateway to Europe for the Coronavirus pandemic. The crisis has raised many questions about our vulnerabilities and strengths. After the emergency, what is our future? What is the new reality in the wake of the [...]
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 [...]
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 [...]
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