EMA’s advice on managing the impact of the war in Ukraine

2022-08-24T16:09:53+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: , , , , , , |

EMA’s advice to sponsors on managing the impact of the war in Ukraine on clinical trials EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war [...]

EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A

2022-08-25T10:19:19+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: , , , , , , , |

EMA has published an updated version of its good clinical practice Q&A 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 [...]

Handover of Expert Panels to EMA

2022-08-26T08:11:55+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: , , , , , , , , , , |

Handover of expert panels on medical devices and in vitro diagnostics to EMA 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 [...]

Notification’s guidelines of serious breaches of Regulation (EU) No 536/2014 / clinical trial protocol

2022-10-06T09:16:12+00:00January 3rd, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: , , , , , |

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol European Medicines Agency published a new Guideline on the reporting of Serious Breaches, that will come into effect on January 31, 2022. Find out: [...]

PREFER patient input to decision making under evaluation

2022-10-06T11:12:50+00:00October 16th, 2021|Categories: Digital Health, Europe, Regulatory|Tags: , , , , , , |

PREFER patient input to decision making under evaluation 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 [...]

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

2022-10-06T12:45:59+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products 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 [...]

EU: EMA expands the use of remote source data verification in clinical trials

2021-02-09T09:57:36+00:00February 9th, 2021|Categories: Clinical Trial, Covid-19, Europe|Tags: , , , , , |

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 [...]

EU: EMA supports digital health technologies in clinical trials

2020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: , , , , |

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 [...]

EMA: Points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials

2020-07-02T08:23:30+00:00July 2nd, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: , , |

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 how [...]

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