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8th Generics and Biosimilars in Russia and EAEU

Successful Market Launch Strategies for Generic and Biosimilar Medicines in Russia and EAEU in the New Regulatory Landscape

21-23 Sep 2013
Moscow, Russian Federation

Conference Workshop

Workshop Title: BIOEQUIVALENCE STUDIES FOR BIOSIMILARS
This interactive practical workshop will enable the participants to analyze Russian requirements to bioequivalence studies for biosimilars in comparison to European regulations and learn how to improve the efficiency of these studies
Workshop Moderator: Konstantin Zakharov // Artem Poltoratsky
Company: Deputy Director, Clinical Clinical Research, Scientific Research Center Eco-Safety // Head of the Department for Clinical Trials, Petrov Research Institute of Oncology

Why You Should Attend

8th Generics and Biosimilars in Russia and EAEU

Over the last few years the regulatory environment in Russia and EAEU has changed drastically. Alongside with the amendments to Russian regulations on development, clinical trials, registration and circulation of medicines, the EAEU Agreements are about to enter into force, which every so often disagree with local legislations. Generic and biosimilar medicines regulation raise even more questions. While the new regulatory initiatives are supposed to give the Russian companies new opportunities for business development, they become an obstacle for foreign pharmaceutical manufacturers. The companies now have to learn to deal with legislative collision and play their cards well to keep the market share and find opportunities for business development.

This premier 8th practical marcus evans conference will look at preparation of companies for business development in the new regulatory environment, effective market launch strategies for generic and biosimilar medicines and market expansion opportunities due to formation of EAEU common market.

Key practical case studies will delivered by AIPM, Pharmstandard, AstraZeneca, BIOCAD, Nanolek.