Author Archives: beawire

Renewal of the drug registration within the framework of national regulation

According to the Federal Law No. 61 “On Circulation of Medicines”, a drug, first entered the Russian market, receives a registration certificate for 5 years. During this period, its effectiveness and safety shall be monitored. Further registration must be confirmed. To do this, it is necessary to collect a certain package of documents and send the dossier for expertise. In

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Diseases of the population of Russia. Epidemiological review (2018)

Perhaps nothing so objectively reflects the reality as figures. Of course, if the numbers are real. They can scare, please, make you think about the past, present and future, or leave indifferent, if they do not specifically concern us. So, “figures” showing the state of affairs of any economic organization, are unlikely to interest the housewife, and the number of

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THE IMPACT OF POTENTIALLY INTERFERING SUBSTANCES ON THE RESULTS OF CLINICAL LABORATORY TESTS

The reliability and accuracy of the sample results in clinical laboratory tests are influenced by many factors, such as the preanalytical factor, sampling, transportation, storage of samples, as well as the presence of interfering substances in the biomaterial samples. Interfering substances are one of the most common errors in clinical laboratory measurements. The presence of these substances in the samples

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About trials on the spot

Note: This article does not apply to in vitro testing of medical devices for diagnostics, as in this case field trials (trials on the spot or so called factory audit for testing) are not applicable. Introduction Tests conducted for the purposes of the state registration of medical devices are regulated by Order No. 2n dated 09 January 2014 “On Approval

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Lasers used in cosmetology

The invention of the laser became one of the most important and significant achievements of the twentieth century. Currently laser technologies are used in almost all spheres of life: science, armaments, industry, etc. Lasers are also widely used in medicine, one of the areas of which is cosmetology. A laser is a device that converts pumping energy (light, electrical, thermal,

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Omics technologies

According to the Deputy Head of the Research Institute of Clinical and Experimental Lymphology for scientific work, Doctor of Medical Sciences Vadim Klimontov: “Omixes” are technologies which are based on the achievements of genomics, transcriptomics, proteomics, metabolomics, that means, sciences that study how the genome is arranged and how the information, which is encoded in it, implemented. How it is

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Lost of accreditation.Who is next?

Technical testing and toxicological testing of medical devices should be carried out in a testing laboratory with the appropriate scope of accreditation. Information on the accreditation of the laboratory can be found in the general access on the website of the Federal Service for Accreditation (RusAccreditation). How to check the scope of laboratory accreditation: Visit the RusAccreditation website in the

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 Testing of a medical device for the purposes of marketing authorisation, particularly on-site visits as one of the testing methods

 Testing of a medical device for the purposes of marketing authorisation, particularly on-site visits as one of the testing methods. Marketing authorisation of medical devices consists of several steps, one of which is testing. Testing could be of three types, namely: Toxicology testing, Technical testing, and Clinical testing (trials) The procedure for the testing mentioned above is set forth in

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