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

2023-03-29T14:01:43+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: , , , , , , |

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 [...]

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

2023-03-29T14:01:51+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: , , , , , , , |

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 [...]

Handover of Expert Panels to EMA

2023-03-29T14:04:04+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: , , , , , , , , , , |

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 [...]

PIC/S revises GMP guide to reflect new EU Clinical Trials Regulation

2023-03-29T14:25:58+00:00February 2nd, 2022|Categories: Compliance, Europe, Regulatory|Tags: , , |

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 [...]

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

2023-03-29T14:47:59+00:00January 3rd, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: , , , , , |

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 [...]

PREFER patient input to decision making under evaluation

2023-03-29T15:51:23+00:00October 16th, 2021|Categories: Digital Health, Europe, Regulatory|Tags: , , , , , , |

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 [...]

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

2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

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 [...]

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

2023-03-31T13:12:41+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

2024-02-02T11:53:30+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 [...]

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