Clinical Trials – Russia & Ukraine – Opportunities and Challenges

Running clinical trials in the BRIC region remains a firm priority for global pharmaceutical and biotech companies pursuing clinical research. Despite recent geopolitical unrest, Russia and its surrounding countries, including the Ukraine, remain popular geographies for companies wishing to conduct research in this geography alone or as part of a multinational multi-center clinical trial.

Russia has the 7th largest pharmaceutical market and the 9th largest population in the world. In 2014 the Ministry of Health of the Russian Federation approved about 750 new clinical trials across all leading therapeutic areas. A recent survey by Ernst & Young found that 80% of leading drug manufacturers and distributors continue, on the whole, to pursue their plans for business development in the Russian market in spite of the unstable political and economic situation and current sanctions against Russia¹.

Featured speaker Mathilde Niessen, Senior Project Manager from Fisher Clinical Services, will share her perspective and suggest best practice initiatives on how to achieve success in clinical research in this region. This webinar will further explore the following topics to enable a well defined, smooth approach that mitigates risk from beginning to end:

• Opportunities presented by this geography – why Russia? – and what makes it conducive to clinical research
• Challenges including Clinical Trial Authorization (CTA) and regulatory timelines; importation requirements; vast country infrastructure; supply chain logistics in regions experiencing conflict; extreme temperature conditions and climate zones; regulatory changes
• Best practices on how to address these challenges
• The importance of a well defined communication plan

This 45 minute webinar will be followed by a Q&A session.

¹ The Russian pharmaceutical industry amid economic sanctions, Ernst & Young, June 2015

Speaker

Mathilde (Tilly) Niessen, Distribution Project Manager, Fisher Clinical Services

Tilly has held the role of Distribution Project Manager at Fisher Clinical Services since 2013, initially with key responsibility for the set up and management of high profile, accelerated studies for a leading Pharmaceutical company. Over the years Tilly’s portfolio of clients has grown and she has been instrumental in ensuring the timely delivery of clinical supplies to many challenging countries, including Russia & Ukraine. In her day-to-day work Tilly has an underlying interest in innovation and a desire to implement process improvements that help facilitate the smooth movement of clinical supplies across borders. Tilly’s career has always been in healthcare and project management. After graduating as a Physiotherapist, Tilly worked as an Occupational Health Case Manager, helping employees to return to work after a period of illness. She proceeded to take on the role of Implementation Coordinator for the same company. This involved the on-boarding of new clients as well as change management and chairing the Change Advisory Board. Tilly is a certified PRINCE2 Practitioner.

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