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
