Employees of the State Expert Center of the Ministry of Health took part in an international seminar devoted to current issues of planning, conducting, and evaluating bioavailability and bioequivalence studies (BioBridge 2018 Bioequivalence and development workshop), which took place on 26-27 September 2018 in Prague, Czech Republic.
More than 200 participants took part in the seminar, of whom about 40 were representatives of regulatory agencies of Europe and Ukraine.
Issues concerning the conduct and evaluation of bioequivalence studies are very topical worldwide, and in recent years, with the aim of global harmonization of approaches, many changes have been taking place in the regulatory documents of the leading regulatory agencies in the world. In this regard, discussion among various industry specialists is becoming increasingly necessary and important.
The seminar devoted considerable attention to important issues highlighted in published guidelines and draft guidelines on approaches to conducting and evaluating bioavailability and bioequivalence studies. During the seminar, open discussions and a constructive exchange took place among regulatory authorities, scientists, researchers, and manufacturers of medicinal products. The information obtained makes it possible to implement and use modern regulatory approaches to conducting and evaluating bioequivalence studies in Ukraine.
