ROMANIA: Important Announcement of ANMDMR to the attention of companies conducting clinical trials

2024-02-29T14:10:08+00:00March 24th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

UPDATED on March 24th, 2020 National Agency for Medicines and Medical Devices in Romania (ANMDMR) issued an important message to the Sponsors of clinical studies in the country. Announcement from March 13th, 2020 in the local language can be [...]

LITHUANIA: Lithuanian Bioethics Committee issues guidelines on clinical research under COVID-19

2024-02-26T16:10:55+00:00March 23rd, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

UPDATE ON March 23, 2020 Lithuanian Bioethics Committee issued guidelines on clinical research under COVID-19. However, further guidance is expected to be soon released by the State Medicines Control Agency under the Ministry of Health of the Republic of [...]

IRELAND: HPRA provides recommendations for clinical research management under COVID-19

2024-02-26T12:16:42+00:00March 23rd, 2020|Categories: Europe, Western Europe|Tags: , , , |

Health Product Regulatory Authority (HPRA) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Ireland and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support. [...]

Italy. Covid-19 infection reaches 59.138 with 5.476 deaths. Slowing trends of new cases and deaths recorded today for the first time.

2024-02-26T15:59:57+00:00March 23rd, 2020|Categories: Covid-19, Europe, Western Europe|Tags: , , , , |

A slowdown of the rising trends in the number of Covid infections and deaths was recorded today by the Italian Civil Protection. Healthcare workers infected rise to 4,824 and now their testing is prioritized. The total lockdown in Italy [...]

SWITZERLAND: New Ordinance for Clinical Trials during COVID-19 Emergency

2024-02-29T14:29:45+00:00March 21st, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

UPDATE ON March 21st, 2020 The Swiss federal government published an ordinance to conduct clinical trials during the COVID-19 emergency. This legislation applies to Sponsors, investigators and project leaders of clinical trials and research projects in Switzerland. It is [...]

Trials made easy: health authorities simplify GCP rules during pandemic

2024-02-29T15:05:31+00:00March 21st, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: , , |

20+ guidelines published last week to RESCUE ongoing trials amid the emergency. All authorities in Europe, Israel, USA and globally allow facilitations for patient safety and continuity of medical research, helping hospitals and sponsors. Immediate measures are needed to [...]

European Commission, EMA and HTA issue harmonized guidance for clinical trials during the COVID-19 pandemic

2024-02-07T15:54:29+00:00March 20th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: , , , |

This guidance includes a harmonised set of recommendations, to ensure the utmost safety of trial participants across the European Union while preserving the quality of the data generated by the trials. It also advises how these changes should be [...]

FRANCE: ANSM offers practical solution to manage clinical trials amid the crisis

2024-02-26T11:01:22+00:00March 20th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

The ANSM, in conjunction with the DGS and the DGOS, offers practical solutions for implementing the necessary adaptations for clinical trials in progress in the current situation. The solutions proposed by the authorities have been established in order to [...]

POLAND: Authorities suspend inspection of clinical trials till the end of April 2020 due to COVID-19

2024-02-29T14:01:20+00:00March 19th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland issued guidelines on clinical research under COVID-19. Inspections activity of clinical trial is suspended until the end of April 2020. The decision to resume the [...]

NETHERLANDS: Central Research Committee announces approval fastrack for trials to develop COVID 19 vaccines

2024-02-29T13:55:20+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

The Netherlands’ Central Committee on Research Involving Human Subjects (CCMO) announced the availability of fast-track approval procedures for clinical trials related to the development of vaccines for COVID-19. To make use of this procedure, please contact CCMO via ccmo@ccmo.nl or telephone [...]

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