Notifications about clinical trials

  • Remember to Enter Start Dates in CTIS

    | 19 February 2025 |

    This is a technical necessity to ensure that the trial, and thus the approval, does not expire.

  • Live streaming of the Danish Medicines Agency's after-work meetings on the revised ICH GCP guideline (ICH E6 R3)

    | 13 February 2025 |

    The Danish Medicines Agency will hold after-work meetings on the revised ICH GCP guideline (ICH E6 R3) on February 27 and 28, 2025, from 14:30 to 18:00. The meetings will be conducted by ICH E6 R3 EWG member and GCP inspector Lisbeth Bregnhøj. You can find the links for streaming in this news.

  • New Protocol Template for Clinical Trials

    | 06 February 2025 |

    We have updated our protocol template to include even more guidance from both the Danish Research Ethics Committees and the Danish Medicines Agency. By starting out from this improved protocol template it can to a higher degree be assured that the regulatory demands to the protocol are met – and hopefully the process of developing the protocol is made easier and better. ​

  • ICH GCP training – what are the expectations?

    | 23 January 2025 |

    ICH E6 revision 3 has now been published. The Danish Medicines Agency anticipate questions regarding the need for training and retraining and therefore publish this Q&A.