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 [...]

GREECE: EOM changes opening hours during COVID-19 emergency

2024-02-26T11:19:29+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

The Department of the General Secretariat of the National Organization for Medicines (EOM) announced the adoption of preventive measures and under the protection of public health against the coronavirus will operate from 10:00 to 14:00 during working days for the [...]

SLOVAKIA: SUKL issues guidance on patients´ risk assessment during COVID-19 emergency

2024-02-29T14:11:03+00:00March 19th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

The State Institute for Drug Control (SUKL) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Slovakia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice [...]

NORWAY: NoMA allows changes and safety measures in clinical research prior to approval during COVID-19 emergency

2024-02-29T13:58:34+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

Norwegian Medicine Agency (NoMA) guided many aspects of clinical research in response to COVID-19 emergency. Meditrial manages several studies in Norway and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice [...]

Meditrial provides rapid workflows to rescue clinical trials during pandemic

2024-02-29T13:46:29+00:00March 19th, 2020|Categories: Clinical Trial, Covid-19, Europe, Innovation|Tags: , , , , |

As the COVID-19 emergency impacts all healthcare sectors, Meditrial provides rapid tools to help industry and researchers rescue their clinical trials. Safeguard of patients’ safety is the key concern, but also avoiding the compromise integrity of important studies due [...]

ITALY activates safeguard procedures for clinical trials during pandemic

2024-02-26T12:32:21+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

The Italian Medicines Agency provides indications regarding the management of clinical trials in Italy during the COVID-19 (coronavirus disease 19) emergency. The guidelines describe the measures to manage clinical trials during the emergency and the exemptions granted. Download in [...]

GERMANY: BfArM provides support for ongoing clinical trials

2024-02-26T11:10:55+00:00March 18th, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

Germany reacts to the pandemic with high attention to ongoing clinical trials. According to the government authority BfArM, protocol deviations and changes may occur with the dynamic risk situation and restrictions due to Coronavirus SARS-CoV-2. A dedicated email, CT-COVID@bfarm.de, [...]

ESTONIA: Regulatory clarification for all concerned parties in clinical trials

2024-02-02T11:56:18+00:00March 18th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

The State Agency of Medicines issued a guideline on clinical trial management which is in effect until the end of the Emergency Situation, which was declared by the Government of Estonia until 1 May 2020. Meditrial manages several studies [...]

FDA GUIDELINE FOR CLINICAL TRIALS OF MEDICAL PRODUCTS DURING PANDEMIC

2024-02-07T16:14:45+00:00March 18th, 2020|Categories: Covid-19, USA|Tags: , , , |

As the COVID-19 emergency impacts all healthcare sectors, the FDA issues guidelines to help industry and researchers. Safeguard of patients’ safety is the key concern, but also avoiding the compromised integrity of important studies due to missing data and [...]

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