International Council for Harmonisation (ICH) to issue revision of E6 (R2) Good Clinical Practice in the fall of 2021

2023-03-31T12:43:00+00:00March 31st, 2021|Categories: Clinical Trial, Compliance, Regulatory|Tags: , , , |

The International Council for Harmonisation (ICH) is working on the revision of E6 (R2) Good Clinical Practice, the guidace addressing GCP to provide a unified standard for the ICH region and to facilitate the mutual acceptance of clinical data. Meditrial [...]

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 [...]

Canada: Health Canada releases guidance on the conduct of clinical trials during COVID-19 pandemic

2024-02-01T16:41:27+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory|Tags: , , , |

Health Canada published two guidance documents aimed at improving clinical trials for medical devices and medicines during the COVID-19 pandemic. New trialsTo reduce regulatory burden, Health Canada has developed a new regulatory pathway, the interim order for clinical trials for medical [...]

Columbia: procedures not related to the COVID-19 emergency

2024-02-01T16:43:42+00:00April 15th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory|Tags: , , , |

In accordance with the provisions of Resolution No. 2020012926 of April 3, 2020 "By means of which temporary administrative measures are adopted within the framework of the health emergency declared by the National Government due to COVID-19" , it [...]

BELGIUM: FAMHP recommends electronic submission during COVID-19 emergency

2024-02-01T16:16:31+00:00March 25th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

UPDATE ON March 25th, 2020 Federal Agency for Medicine and Health Products (FAMHP) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Belgium and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel [...]

AUSTRIA: BASG on safety measures for clinical research during COVID-19 emergency

2024-02-01T15:07:37+00:00March 17th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

Austrian Health Authority (BASG) issued recommendations on measures for patient safety and communication with the authority during COVID-19 emergency. Meditrial manages several studies in Austria and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to [...]

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