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Recent Changes in Clinical Trial Authorization in Eastern Europe

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Abstract

The aim of the present work was to discuss, from the regulatory point of view, the recent developments in clinical trial authorization in Eastern European countries. The study was based on a questionnaire sent to drug regulatory agencies or clinical experts in 12 countries as well as on the author’s personal experiences. Very fast changes in ethical approval, good clinial practice (GCP) application, and its compliance monitoring could be observed, especially in countries associated with the European Union. The impact of the newly accepted International Conference on Hamonization GCP is also likely in Eastern Europe

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Authors and Affiliations

  1. National Institute of Pharmacy, Budapest 5, P.O. Box 450, H-1372, Hungary

    Tamás L. Paál (Director-General, Head)

  2. Department of Pharmacy, “Haynal Imre” University of Health Sciences, Budapest, Hungary

    Tamás L. Paál (Director-General, Head)

Authors
  1. Tamás L. Paál
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Paál, T.L. Recent Changes in Clinical Trial Authorization in Eastern Europe. Ther Innov Regul Sci 31, 151–155 (1997). https://doi.org/10.1177/009286159703100122

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