ClinStar VP and General Counsel Leon Dzivinsky to speak on Conducting Clinical Trials in Russia Under the New Regulations: A One Year Review
SAN FRANCISCO--(BUSINESS WIRE)-- ClinStar, LLC, an established clinical research organization providing clinical research services in the emerging markets of Russia and Eastern Europe to the biopharmaceutical industry, announced today that VP and General Counsel Leon Dzivinsky will speak at VIBpharma’s Outsourcing in Clinical Trials West Coast conference, February 15-16, at the San Francisco Airport Marriott Waterfront in Burlingame, CA.
“The biopharmaceutical industry is facing unprecedented pressures including looming patent cliffs, spiraling development costs and slashed R&D budgets. As a result, more and more biopharmaceutical companies are looking to emerging markets to offset these pressures,” says Mr. Dzivinsky. “For many, however, the enticement of conducting clinical research studies in emerging markets is over shadowed by the fear of prolonged study start-up times, unknown regulation and logistics requirements and political uncertainty.”
During the presentation scheduled for Wednesday, February 15 at 12:15 p.m., Mr. Dzivinsky will explore how to effectively navigate these challenges in Russia and parts of Eastern Europe and will demonstrate how these countries are not only effective in rescue trials but should be included upfront as an integral part of a biopharmaceutical company’s global clinical trial plans.
Specifically, Mr. Dzivinsky will:
- Evaluate the goals and benefits of Russia's new clinical trial regulations effective September 2010
- Examine major changes and new requirements resulting from the legislation
- Uncover challenges related to the new regulations and status of implementation
- Demonstrate clinical trial metrics for studies being conducted in Russia before and after introduction of the new law
About ClinStar, LLC
ClinStar is one of the most prominent clinical research organizations in the emerging markets of Eastern Europe and the Baltics with more than 10 years of expertise in Phase I-IV clinical research studies in multiple therapeutic areas. Headquartered in San Francisco, California, ClinStar manages studies from its offices in Russia, Ukraine and Belarus, with total staff of over 260 people. Its portfolio contains over 130 clinical trials conducted for US and European pharmaceutical and biotechnology companies. More information is available at www.clinstar.com.
Heather Newbold, 1-919-354-3573 ext. 276
Associate Director, Marketing
KEYWORDS: United States Europe North America California Russia
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical