Vitalii Usenko

Vitalii Usenko

Medical Director, Farmak (Ukraine)

Practical experience in pharmaceutical sector including international clinical trials since 1995 in the leading pharmaceutical R&D transnational companies (GlaxoSmithKline, Pfizer, F. Hoffmann-La Roche, Sanofi in Ukraine.)  Experience of work as visiting doctor in Austria.

Practical experience of work in international projects such as projects of TACIS of EU Commission related to pharmaceutical sector of Ukraine. Expert advice on marketing, general healthcare, legislative and regulatory issues. Developed recommendations on the harmonization of the Ukrainian pharmaceutical legislation with European Union (many of recommendations done in project were implemented in Ukraine).

As the Secretary of the Healthcare Committee in AmCham (American Chamber of Commerce in Ukraine) during 2004 – 2009 actively participated in working groups related to healthcare sector in Ukraine.

Developed within medical department from the scratch new clinical trials division of Pfizer in Ukraine. This division was among the large ones in Eastern Europe in the ranking within company, more than 40 people were engaged in medical department. Department occupied decent place in Ukraine in volume of the clinical trials conducted through local affiliates. Clinical trials projects covered 18 regions of Ukraine with involvement of more the 200 sites and around 600 investigators and co-investigators. Total number of clinical trial projects in Ukraine during 2004 – 2009 was more than 40 projects.

In Hoffman-la Roche was responsible, among other things, for the local co-ordination of global biosimilars strategy in Ukraine, dual branding projects, participation in the implementation of local manufacturing biosimilars project for three brands in Ukraine.

Author or co-author of more than 200 articles and books, among them such books as “Licensing in the European Union: pharmaceutical sector”, 1998; “Strategic management and marketing in the practice of pharmaceutical companies” together with Vladimir Biloshapka and Gleb Zagoriy (2001), “Pharmaceutical sector: Essentials of the modern pharmaceutical legislation in the EU” (2002, updated version in 2013); “Pharmaceutical sector: Common Technical Document in EU”, 2002; “Pharmaceutical care” together with Prof. Dr. Igor Zupanets (2002), “Lectures in Pharmaceutical Care”  together with Prof. Dr. Igor Zupanets  (2003), “Pharmaceutical sector: Rules governing clinical trials in the EU” (2005), Practical guidelines “Modern Principles of Medicinal Products Bioequivalence Evaluation” together with Prof. Dr. Igor Zupanets  and group of authors (2017) Received award “Panatseya-2017” for these guidelines.

Since 2015 works in the Ukrainian pharmaceutical company Farmak JSC. Responsible for the popularization of concepts of bioequivalence, modern medicinal products classifications and real-world evidence (RWE) and real-world data (RWD) in Ukraine, implementation of pharmacovigilance database in line with EU and Ukrainian standards, implementation of GCP compliance, medical compliance for promotional and non-promotional materials in Farmak JSC. More than 30 publications on bioequivalence, modern medicinal products classifications and real-world evidence (RWE) and real-world data (RWD) in Ukraine during 2016-2018.