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European Pharmaceutical Contractor
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For anyone working in clinical trials, Yugoslavia is not the first place that springs to mind. Previous conflict and civil unrest have lead to a general lack of confidence, resulting in a reluctance within the industry to gamble their precious resources in this relatively unknown area. Historically, however, many successful trials have been carried out in this country, and now Yugoslavia is determined to put itself back on the map. This article will cover the process of obtaining regulatory and ethical approval for clinical studies and will provide the reader with all the information needed to be convinced that Yugoslavia is very much a re-emerging market.
Background
The Federal Republic of Yugoslavia consists of the Republics of Serbia and Montenegro and has a population of approximately 10.4 million people. The country is located at the Balkan Peninsula in South Eastern Europe. It is bordered by the Adriatic Sea, Albania, Macedonia, Bulgaria, Romania, Hungary, Croatia and Bosnia and Herzegovina.
A negative population growth rate has been noted in Serbia and Montenegro in recent years, which is largely a consequence of migration during the war and the resulting poor economic climate. Average life expectancy is estimated to be 72.4 years in Serbia (male 69.3 and female 75.7), and 75.5 years in Montenegro (male 71.5 and female 79.8).
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By Helen Springford, Director of European Business Development, and Pavle Vukojevic, Clinical Research Associate for Pharm-Olam Internationald
Helen Springford graduated with an honours degree in Nursing Sciences in 1990. As a Senior Clinical Project Manager, Helen has recently been appointed Director of European Business Development for Pharm-Olam International, a multinational CRO with headquarters in Ascot, UK and Texas, USA. Prior to this, she spent four years co-ordinating hospital-based clinical trials and one year managing an SMO based in central London. In 1996 she made the transition to industry, working as a Clinical Project Manager at PRA and Glaxo Wellcome.
Pavle Vukojevic graduated from Belgrade Medical School in 1988. Since 1991 he has worked within the Institute of Rheumatology in Belgrade, initially as a Clinical Doctor and since 1996 as an Internal Medicine Specialist. In the same year he completed his MSc in Immunology. He has been working as a Professor's Assistant for Internal Medicine at the University of Belgrade Medical School since 1998. Pavle is Associate Editor for Rheumatology of Interna Medicina (Internal Medicine), the official journal of the University of Belgrade for Internal Medicine's Medical School. Pavle is also the Associate Editor of Acta Rheumatologica Belgradensia, the official journal of the Rheumatology Section of the Serbian Medical Society. Since 1997 he has worked as a Clinical Research Associate for Pharm-Olam International and has been pivotal in re-establishing trials in the region and the expansion of Pharm-Olam International Yugoslavia.
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