HUNGARY: Update on measures for clinical studies under COVID-19

2024-02-26T11:39:00+00:00March 25th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

UPDATE ON MARCH 25th, 2020 OGYEI National Institute of Pharmacy and Nutrition updated special measures to face COVID-19 emergency. Updated instructions concern among others: Authorization procedure for new study applications or amendments:  sponsors should submit as "urgent safety measure" [...]

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

2020-03-24T10:20:45+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 found [...]

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 [...]

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

2020-03-19T17:31:04+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 inspection [...]

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

2020-03-19T14:14:16+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 and [...]

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 [...]

LATVIA: SAM recommendations to ensure continuity of clinical trials during pandemic

2024-02-26T16:07:57+00:00March 17th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

State Agency of Medicines (SAM) of Republic of Latvia issued guidelines on clinical research under COVID-19. Meditrial manages several studies in Latvia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for [...]

Czech Republic Authority SÚKL issues clinical trial instructions for subject safety and data validity during COVID-19 emergency

2024-02-02T10:16:28+00:00March 16th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , , |

The Czech Authority  State Institute for Drug Control (SÚKL) has issued an opinion on a clinical research under current COVID-19 pandemic on 13 March and provided additional clarifications regarding the management of patients visits and study products on 16 [...]

SLOVENIA: JAZMP operates smoothly under the current emergency

2020-03-13T13:33:57+00:00March 13th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

Public Agency of the Republic of Slovenia for Medicines and Medical Devices (JAZMP) has issued a business notification to inform all interested stakeholders and the public that JAZMP’s operations are running smoothly for the time being. Moreover, JAZMP is taking [...]

FINLAND: FIMEA requires on-site monitoring reduction during COVID-19 emergency

2024-02-26T10:58:42+00:00March 13th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

Fimea provided guidance on trial monitoring plans during COVID-19 emergency. Meditrial manages several studies in Finland and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support. Monitoring activity Sponsors [...]

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