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Year 2019 ( Hide...)

March’19 
  • The Database lock was reached in the bioequivalence study of an anticancer drug.
  • The efforts of a group of Russian experts, including representatives of Almedis, were crowned with success - the next version of the dictionary for coding medical terms MedDRA 22.0 includes Russian language
    https://www.meddra.org/sites/default/files/messenger/documents/000308_messenger_march_2019.pdf
    https://www.meddra.org/news-and-events/messenger
  • Almedis, as a member of the Roszdravnadzor working group, participated in the preparation of materials for the training program for employees of territorial bodies of Roszdravnadzor, "Good clinical practice. Methodological basis of the inspection. The release of the program is scheduled for April 2019.
February’19 
  • ACTO has published the latest results of monitoring the timeline for obtaining Ministry of Health permission to conduct clinical trials http://acto-russia.org/index.php?option=com_content&task=view&id=29
  • The last patient last visit was conducted in the bioequivalence study of an anticancer drug.
  • An open letter was issued by the ACTO to members of local ethical committees (LECs) and principal investigators regarding bringing SOPs of LECs in compliance with current legislation. Particular attention is paid to the need to bring the current safety information processing practice of LEC in accordance with international standards and local requirements http://acto-russia.org/index.php?option=com_content&task=view&id=376
  • Almedis representatives took part in the ACTO business lunch devoted to the discussion of legal conflicts regarding submission of clinical trials reports to the regulatory authorities of the Russian Federation: requirements set forth in legislation cannot be implemented in practice for multicenter studies, primarily for multinational multicenter studies. We will follow up the situation in this matter.
  • The recruitment for the next course of webinars "Good Clinical Practice for Investigators" was opened at the Department of Clinical Research of the ANO DPO "Institute of Laboratory Medicine" https://dpo-ilm.ru/education/course/53
January’19 
  • An observational study of patients preferences in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) has been launched.
  • The database was locked in the international multicenter Phase III clinical study of antiplatelet therapy in patients with acute coronary syndrome after pharmacological thrombolysis (TREAT). The study was initiated and organized by researchers from the Cardiological Institute HCor, Sao Paulo, Brazil. In Russia, 700 patients were enrolled in 20 clinical sites.

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