k.janecek2023-03-29T14:01:43+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: Clinical Trial, Compliance, EMA, Europe, MedTech, Regulatory, Regulatory Affairs|
EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]
k.janecek2023-03-29T14:01:51+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: Clinical Trial, Compliance, EMA, Europe, European Union, medicines, Regulatory, Regulatory Affairs|
The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors [...]
k.janecek2023-03-29T14:04:04+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, EMA, eumdr, Europe, European Commission, IVD, IVDR, MDR, Medical Devices, Regulatory, Regulatory Affairs|
Now, the European Medicines Agency has control of the Expert Panels on medical devices and in vitro diagnostic medical devices. On 1 March, the coordination Secretariat of the Commission’s expert panels on medical devices and in vitro diagnostic medical devices has been [...]
k.janecek2023-03-29T14:25:58+00:00February 2nd, 2022|Categories: Compliance, Europe, Regulatory|Tags: EMA, Europe, Regulatory|
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its good manufacturing practice (GMP) guide to reflect the new EU clinical trials regulation (CTR), which took effect on January 31, 2022. Investigational medicinal products shall be manufactured by applying manufacturing practices [...]
adminMTE_04792023-03-29T14:47:59+00:00January 3rd, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: Compliance, ctis, EMA, Regulatory Affairs, regulatorycompliance, SAFETY|
European Medicines Agency published a new Guideline on the reporting of Serious Breaches, that will come into effect on January 31, 2022. Find out: ✔ how to report serious breach ✔ responsibilities of the different parties involved in the notification ✔ examples [...]
adminMTE_04792023-03-29T15:51:23+00:00October 16th, 2021|Categories: Digital Health, Europe, Regulatory|Tags: EMA, medicines, MedTech, Patient Experience, Pharma, Regulatory Affairs, Technology|
PREFER project has developed a framework with points to consider when selecting methods for industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical product decision making. European Medicines Agency and EUnetHTA - European Network [...]
k.janecek2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: Clinical Trial, Complex Generic Drugs, DRUGS, EMA, Europe, European Union, FDA, Generic Drug, Hybrid Medicines, Innovation, medicines, PSA, Regulatory, USA|
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]
adminMTE_04792023-03-31T13:12:41+00:00February 9th, 2021|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, European Commission, Remote Source Data Verification, rSDV|
The European Commission and European Medicines Agency’s updated the guidance on managing clinical trials conducted during the COVID-19 pandemic by expanding the use and scope of remote source data verification (rSDV) in clinical trials. While previous versions of the guidance [...]
adminMTE_04792020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: Clinical Trial, Digital Health, EMA, Europe, Innovation|
Digital health technologies are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, "a multidisciplinary group that includes scientific, regulatory and legal competences [...] to provide [...]
adminMTE_04792024-02-02T11:53:30+00:00July 2nd, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA|
The European Medicine Agency (EMA) released a guidance to illustrate some points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials. "At this point in time it is not possible to provide general advice on [...]
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