Tag Archives: Head

Registration of pharmaceuticals for human use in Ukraine

The procedure for registration of medicines in Ukraine is in the stage of harmonization with the registration in the European Union, which leads to regular updating of the regulatory framework and some changes in the organization of work on registration. However, the new registration of pharmaceuticals for human use now includes three main stages: preparatory step, registration process and fulfillment

Read more

The system of state regulation of registration of medicines in Ukraine

The procedure of registration, re-registration of medicines, as well as amendments to the registration dossier in Ukraine is somewhat different from the Russian procedures. For example, in Ukraine it is mandatory to comply with the IFU for a drug with the instructions of the reference European state (if the drug is registered in the EU), the national expert center of

Read more

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

Read more

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

Read more

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

Read more

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

Read more

 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

Read more

In vitro diagnosis of autoimmune diseases

Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against the body’s own antigens (AG). Autoimmune mechanisms are at the heart of many organo-specific and systemic diseases.  These diseases include rheumatoid arthritis, insulin-dependent diabetes mellitus, ulcerative colitis and other less known diseases. The resulting autoimmune process is usually chronic and

Read more
« Older Entries