We answer on most popular and interesting questions about pharmacovigilance

Pharmacovigilance: on the formation of periodic updated safety reports

By |November 17th, 2021|Categories: Other|Tags: , , , , , , |

Currently, the development of analytical databases on the Internet makes it possible to determine the relevance of certain keywords. Among others, "pharmacovigilance, cheap" and "full range of pharmacovigilance services" occupy quite high positions. And this is a fairly new trend. So what do users who search for "pharmacovigilance, cheap" or [...]

Composition of a registration dossier

By |November 9th, 2021|Categories: Other|Tags: , , , , |

Our company can perform:- preparation of drug samples for evaluation during state registration,- writing sections 2,4-2,7 of the registration dossier,- amending the already submitted documents,- advising on the preparation of the dossier,- if necessary, to finalize the documents.At the time of submitting an application for state authorization of a medicinal [...]

Boequivalence studies

By |October 25th, 2021|Categories: Other|Tags: , , , , , , |

Bioequivalence (pharmacokinetic equivalence) is the degree of similarity of a pharmaceutically equivalent drug to a reference drug (usually a generic drug to an original proprietary drug). Determined experimentally, in vivo. As you know, after the development and registration (authorization) of a medicinal product, the product enters the pharmaceutical market. The [...]

Medicinal product authorization

By |October 25th, 2021|Categories: Other|Tags: , , , , |

In order for a drug to enter the Russian market, it is required to go through several stages, the very first of which is an affirmative registration, or revision examination. The process involves checking your product by the state for safety, efficacy in relation to the indicated pharmacological properties. The [...]

National Pharmacovigilance center is an adherent of the process approach

By |September 29th, 2021|Categories: Center news, Other|

The process approach is the most effective method of organizing the effective work of the company, starting from the late 70s of the last century to the present, and there is every reason to believe that it will remain so for a very, very long time. The essence of the [...]

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