An Evaluation of Clinical Trial Quality in Russia / Ukraine Compared to Western Europe, Eastern Europe and Other Emerging Markets

With patient recruitment rates up to twenty times faster than the West, the biopharmaceutical industry is embracing the undeniable benefits of conducting clinical trials in emerging markets such as Russia. In fact, 33% of all drugs approved by the FDA and 48% of all drugs approved by the EMEA in 2011 included data from clinical trial research conducted in this region.

Yet with benefits like this, why isn’t this number closer to 100%? For many, the enticement for conducting clinical trials in emerging markets is over shadowed by the fear of unknown regulatory and logistics requirements, prolonged study start-up times and overall clinical trial quality.

During the webinar, David Passov, Senior Vice President of Eastern Europe for ClinStar, A PRA Company, and Dr. Stanislav Gneushev, Director of QA for ClinStar, will evaluate the quality of clinical trials being conducted in Russia / Ukraine compared to Western Europe, Eastern Europe and other Emerging Markets based on the results of recent FDA inspections conducted at clinical trial sites in these regions. In addition, they will:

• Discuss key elements of successful Quality Management Systems for niche CROs operating in Russia, Ukraine, Belarus and the Baltics
• Provide practical advice on SOP development
• Present training approaches for optimal coaching of clinical monitors
• Consider what quality assurance activities are required in Russia and parts of Eastern Europe to ensure continuous quality improvement of clinical studies

Speakers

David Passov, MBA Senior Vice President, Eastern Europe, ClinStar, A PRA Company

David Passov was born in Estonia when it was part of the Soviet Union. He attended Tartu University Medical School prior to moving to the US in 1993. He received a degree in biology from Boston College and following a short basic science research tenure at Massachusetts General Hospital’s neuroscience department entered the bioPharmaceutical industry in 1996.

Since that time, Mr. Passov has held positions in clinical operations, project management, market research, business development, commercial operations, and general management at various small and large US-based CROs. He also received an MBA from the Executive MBA Program at Northeastern University (Boston, MA) in 2002. Mr. Passov joined ClinStar in 2005 and until the recent acquisition by PRA International, held a position of President and CEO. Currently, he is responsible for management of the Eastern European region and holds a position of Senior Vice President. He is a native Russian speaker and for the past eight years has spent the majority of his time working in Russia and Eastern Europe.

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Stanislav Gneushev, MD, MRQA, Director, Quality Assurance, ClinStar, A PRA Company

Stanislav Gneushev has more than 15 years experience in the clinical research industry. Having joined ClinStar in 2004, Dr. Gneushev currently serves as Director, Quality Assurance for the company. Dr. Gneushev has performed approximately 100 audits of investigators sites and vendors across several countries (primarily in Russia and Ukraine), accompanied more than 80 external audits and managed nine FDA inspections of investigational sites in Russia and Ukraine. Under his supervision, ClinStar has implemented an excellent quality management system.

Dr. Gneushev obtained his medical degree from Moscow Medical Academy in 1995. He began his career in clinical research in 1997 as a sub-investigator for several trials in Russia. Prior to joining ClinStar, Dr. Gneushev worked in various roles with Quintiles’ Moscow branch office and J&J PRD (division of Janssen Pharmaceutica). Dr. Gneushev has been an active member of the Drug Information Association since 2005 and a Member of Research Quality Association (former BARQA) since 2010.

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