Abstract
Introduction: Modern trends in drug production and traffic of drugs as a primary marketing resource of high quality efficient and safe drugs have an important task to provide safe, effective and quality medicines through clinical trials. Topic: Overview of current regulations established in the field of clinical trials of drugs and the importance of carrying out clinical trials is pointed herein. Methods: Pursuant to the applicable regulations in the Republic of Serbia and those established at the level of the European Agency (EMA) is provided an overview of the key elements essential for the objective procedures carried out in clinical trials of drugs in Serbia. Conclusion: Modern drug therapy today is exposed to serious challenges given the numerous studies in the field of medicine and pharmacy carried out in the world today. Clinical trials are particularly vulnerable segment in this area and require the participants in these processes to be highly educated and to have the serious ethical approach to all stages of the process.
Highlights
IntroductionModern trends in drug production and traffic of drugs as a primary marketing resource of high quality efficient and safe drugs have an important task to provide safe, effective and quality medicines through clinical trials
Clinical trial - any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its safety and/or efficacy his includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State
Regulations applied within clinical trials [1] in Serbia are in line with European regulations more precisely with the Main EU Directive- EU DIRECTIVE 2001/20 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 and THE COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005
Summary
Modern trends in drug production and traffic of drugs as a primary marketing resource of high quality efficient and safe drugs have an important task to provide safe, effective and quality medicines through clinical trials. Topic: Overview of current regulations established in the field of clinical trials of drugs and the importance of carrying out clinical trials is pointed . Methods: Pursuant to the applicable regulations in the Republic of Serbia and those established at the level of the European Agency (EMA) is provided an overview of the key elements essential for the objective procedures carried out in clinical trials of drugs in Serbia. Conclusion: Modern drug therapy today is exposed to serious challenges given the numerous studies in the field of medicine and pharmacy carried out in the world today. Clinical trials are vulnerable segment in this area and require the participants in these processes to be highly educated and to have the serious ethical approach to all stages of the process
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