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THE VOLUME OF RUSSIAN PHARMACEUTICAL MARKET 2016-2019
Russian pharmaceutical market size in 2016 reached 1,344 billion rubles, which is 7% higher than a year earlier, and in 2017 reached 1,629 billion rubles, which is 8% higher than in 2016. Drug sales in physical terms increased by 6% to 6.3 billion packs. The positive dynamics in packages in 2017 indicate an improvement in…
CLINICAL TRIALS TYPES AND DESIGN
A clinical trial of a drug is a systemic study of a medicinal product through its use in humans to assess its safety and/or effectiveness, as well as to identify and/or confirm its clinical, pharmacological, pharmacodynamic properties, assess absorption, distribution, metabolism, excretion and/or interaction with other medicinal products. Such studies are conducted by the fundamental…
Contact person for pharmacovigilance
Pharmacovigilance is an integral part of international cooperation In today’s world. Continuous pharmacovigilance activities must be carried out in all countries where a pharmaceutical company’s products are manufactured. However, this company faces many challenges: starting with the language barrier and ending with the peculiarities of local legislation. In this article, we will try to understand…
Roszdravnadzor extend the powers of inspection
The Russian Ministry of Health has developed amendments to the Regulation on the Federal Service for Surveillance in Healthcare. The draft was prepared to implement the Agreement on Common Principles and Rules of Circulation of Medical Devices and Medicines in the Eurasian Economic Union (EAEU). The draft provides for the formation of common markets for…
Readability User Testing of Package Information Leaflets (PIL) in EAEU
The package information leaflet(PIL) is a document that contains brief information about a medicinal product. The PIL is a mandatory document in the state registration of medicinal products for medical use. patients can easily obtain and understand the necessary information from the package insert. The key point in the development of the PIL is how…