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European Pharmaceutical Contractor
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| Seen by many commentators for years as a potential research-centric hotspot, Jennifer Felenda and Jörn Gatermann of Gatermann Clinical Research Consulting weigh up the benefits and disadvantages of conducting clinical trials in Eastern Europe
Eastern Europe is an attractive place for clinical research and the production of pharmaceutical products because of the very high recruitment rate compared to that of Western Europe or the US. The investigators, study nurses and monitors are qualified and very motivated. Furthermore, it is easier to find patients to participate in clinical trials. Patients in this region tend to be relatively under medicated, thus reducing the risk of them using competing medications and compromising the integrity of the final data. However, there are some handicaps. Language can present a problem, especially the Cyrillic scripture; a further disadvantage could be the geographical range.
ECONOMY
Eastern Europe is increasingly developing a potential pharmaceutical business region. During the last five years, the growth market was at eight per cent in the 15 EU states. Because of stricter price control measures set by governments in Western Europe, revenue flows have reduced to pharmaceutical companies, compelling them to cut back on clinical research and development. However, in the new EU states since 2004 – Estonia, Latvia, Lithuania, Malta, Poland, Slovakia, Czech Republic, Hungary and Slovenia – the market grew to 16.5 per cent. The potential for economical growth is large; many western pharmaceutical companies have recognised the opportunity for investment. The tax rates are lower in Eastern Europe than the Western states and they extend favour of taxes to foreign investors. For example, in the Czech Republic taxes don’t need to be paid in the first 10 years if defined premises are fulfilled. Meanwhile, in Lithuania’s free trade area the investors are exempt from taxes for six years and regular taxes range from 15 per cent in Latvia to 25 per cent in Lithuania. |
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Jennifer Felenda works as coordinating monitor (extern) at Schwabe GmbH & Co KG in Karlsruhe. She trained at a veterinary hospital for horses in Kirchheim for three years before studying Agro- Biology at the University of Hohenheim. Having completed her diploma and a thesis on ‘Efficacy and tolerability of an inactive chlamydia-vaccine in field conditions’, Jennifer became a CRA at the clinical research consulting firm, Jörn Gatermann, in 2005.
Jörn Gatermann completed his MSc in Biology in Boulder, USA, before working in a number of positions within the animal healthcare sector, including SmithKline Beecham Animal Health Care, Munich, Germany and Pfizer Animal Health Care, Karlsruhe, Germany. In 1996 Jörn started work at PPD Pharmaco, a CRO based in Karlsruhe, Germany, as a CRA, later progressing to Senior CRA. In 1999 he became a Freelance Clinical Research Professional, Senior CRA and owner of a small German and Swiss CRO. |
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