Marie Doyle-Rossi

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Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic

On 28 April 2020, the European Commission published further Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (the “Guidance”), supported by the European Medicines Agency (EMA) and the national Heads of Medicines Agency (HMA).  The Guidance is an update to the previous version published in late March (see InsideEULifeSciences blog post … Continue Reading

Ireland’s HPRA to fast-track review of Covid-19 related Clinical Trials and Clinical Investigations

The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19. The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19). Applications for clinical trials of human medicines or clinical investigations of medical devices … Continue Reading

MHRA announces a risk-based prioritisation of on-site Good Practice inspections during COVID-19

On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19.  The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as office-based assessments and information-exchange with … Continue Reading

EMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic

On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance).  The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA). The Guidance provides information on changes and protocol deviations that … Continue Reading
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