Comparative Costs of Clinical Development in CEE and Other Regions

is being presented by Dr. Malgorzata Szerszeniewska, CEO, of Easthorn Clinical Services in CEE and airs on Wednesday, March 24, 2010. For more details or to register, please visit our site at www.fxconferences.com

It has recently been shown that the cost of clinical trials may play a crucial role in the drug development process. A lot of the most innovative biotech companies struggled financially last year and many programs have been put on hold or cancelled due to cash flow problems. A lot of companies have had difficulties in finding partners to help them financially to complete even very promising programs. That is why the cost of conducting clinical trials has become one of the major factors for pharma companies’ drug development strategies, their pipelines, and their CRO selection criteria. As market volume shrank CROs had to compete for fewer studies and price has become an important selection criterion.

This presentation provides a comparison of clinical trial costs in central and eastern europe and other representative regions. Our speaker addresses a variety of factors influencing the costs and discusses the dynamics and directions of recent changes. This information is of use in future budget planning, strategic country selection for specific clinical trials and minimizing financial surprises while running trials in CEE.

Regulatory Considerations for R&D in Central & Eastern Europe

Central and Eastern Europe continues to be an attractive place for conducting clinical trials, with rapid patient recruitment and high quality of data. At the same time, the clinical trial industry's single greatest challenge continues to be the regulatory process, which has a key impact on the duration of the study start-up period and on timely patient recruitment.

Regulatory requirements in CEE countries went through dynamic changes within the last couple of years, mostly as a result of the accession of several countries to the European Union, as well as increasing demand for the adjustment of local regulations to international standards coming from the pharma industry. However, regulatory changes still seem to be an ongoing process, and the greatest challenge for sponsors and CROs.

This presentation focuses on major regulatory-related problems, with special attention to site contracting problems, and show practical ways of overcoming them in order to speed up the drug development process.

Regulatory Considerations for R&D in Central & Eastern Europe is being presented by Dr. Malgorzata Szerszeniewska, CEO, with Unimed and airs on Tuesday, July 7, 2009. For more details, please visit our site at www.fxconferences.com