Conducting Drug Trials in Central & Eastern Europe

Over the next several months, ForeignExchange will present a series of audio conferences featuring expert speakers from Covance discussing the key benefits and drawbacks of using non-traditional sites for conducting clinical research.

In this first first presentation, we focus on the opportunities present in Central and Eastern Europe. This presentation will highlight the current status of the health care system in this region, and how it creates a propitious environment for clinical research business development, boasting rapid recruitment and high quality data.

Conducting Drug Trials in Central & Eastern Europe was presented by Dr. Malgorzata Szerszeniewska, Director of Strategic Development, Central & Eastern Europe, with Covance and is previously recorded. To download this event, or for more details please visit our site at www.fxconferences.com

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

Clinical Research in Central & Eastern Europe: Developments and Challenges

In recent years the countries of Central and Eastern Europe have seen many political and economic changes which have affected the clinical research market. Changes in EU member status, economic standards, labor policy and political changes all effect the environment for clinical trials in this region. In some countries these changes are leading to a less competitive arena for clinical trials, as evidenced by more regulatory hurdles, saturation of sites, and highly unstable labor markets for clinical research personnel as the demand for experienced staff outweighs the supply.

At the same time, there are new countries on the horizon which are just getting started in clinical trials and could offer many opportunities but also come with their challenges. Central and Eastern Europe can still provide excellent recruitment with costs savings but the planning of studies needs to be done with more sophistication than was previously required to get good results.

This presentation focuses on the current and future challenges related to the clinical studies in the region, provide background on the forces that have created the current picture and suggest strategies for success in the future based on actual case studies and experience.

Clinical Research in Central & Eastern Europe: Developments and Challenges was presented by Dr. Malgorzata Szerszeniewska, President, with AbCRO and aired on 2008-07-10. For more details, or to download this conference please visit our site at www.fxconferences.com

Determining Feasibility in Global Clinical Trials

The single greatest challenge to drug development today is successful patient accrual. The sheer volume of actively recruiting trials advertised by the NIH -- nearly 16,000 in 2006 -- illustrates the extensive competition for patients to participate in clinical trials in the United States. In an effort to access more patient populations to address these issues, it has become necessary to include a global mix of countries.

The key to including sites outside the United States is understanding exactly where the selected patient populations are located. Detailed feasibility is a critical step to planning and conducting successful global clinical trials. Understanding the medical standards of care, local healthcare systems, national health insurance and reimbursement, drug importation and tax implications, local regulatory requirements and treatment paradigms are all essential to determining where globally to place a specific clinical trial.

This presentation focuses on how to perform global feasibility to aid in the planning and conduct of clinical trials to economize your development times and clinical trial costs and explores the benefits of including regions such as Eastern Europe, Latin America, Asia and India.

Determining Feasibility in Global Clinical Trials was presented by Kent Thoelke, Sr. Vice President, with PRA International and aired on 2007-08-02. This conference is available for download at www.fxconferences.com