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SUMMARYIntroduction: Spontaneous reporting of adverse reactions is of greatest importance for obtaining information about adverse drug reactions (ADRs) after granting the marketing authorization. The most important role and also the greatest responsibility belong to healthcare professionals. Their active participation is a prerequisite for the existence of an eff ective national drug safety monitoring. Methods: This paper examines the legislative framework concerning the pharmacovigilance system in Montenegro. The information was collected from scientifi c articles and the website of the Agency for Medicines and Medical Devices of Montenegro. Topic: Key segments of pharmacovigilance system are presented, with a special reference to the importance of spontaneous reporting of ADRs, results of spontaneous reporting of ADRs according to the latest Agency's Annual report on the results of spontaneous reporting of adverse reactions to medicines, possible reasons for underreporting ADRs, as well as the new EU regulation on pharmacovigilance. Conclusions: Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance systems. Hence, continuous education of healthcare professionals is needed, with the aim of improving their awareness of the importance of ADRs and risk factors that lead to them, in order to reduce the incidence of ADRs and to increase the number of reported suspected ADRs.

e97 academia and the pharmaceutical industry and offers internships to undergraduate (bio-)medical students. During these internship, students get hands-on experience in clinical pharmacology research. The objective of the study was to assess the clinical pharmacology research internships at the CHDR using an online survey of (former) interns. Areas of interest included general perceptions of the internship and a comparison with academic research internships. Methods: An anonymous online Google Forms® survey with multiple choice, multiple answer and open-ended and Likert-scale questions-was sent to all students that started an internship at the CHDR between 2007-2014. Results: The response rate of the online survey was high (53 students, 61%). Most students gave the internship an overall rating of good (43%) or excellent (42%), and 80.5% strongly agreed that their training at the CHDR was helpful to their career. Many students considered their internship at the CHDR to be (much) more broad (58%) and outcome-driven (50%), compared to academic research internships. Although CHDR has a commercial setting, it was not considered a major distraction by 98% of the interns. A Wilcoxon rank-sum test revealed a significantly lower score of pre-Master students in both "Own knowledge of clinical research" and "Link between internship and knowledge from their study" when they were compared to Master students (both P < 0.01). Conclusion: The clinical pharmacology research internships at the CHDR are perceived by most students as having a good or excellent quality, and being helpful to their career. Pre-Master students might benefit from additional guidance to ensure a sufficient knowledge level for an effective internship.

SUMMARYIntroduction: Medical Dictionary for Regulatory Activities (MedDRA) is a medical coding dictionary which is designed in order to be used by regulatory authorities, pharmaceutical companies, clinical research organizations and health care professionals, i.e. all participants in the system of medicines safety monitoring. Methods: This article describes process which is used for medical coding in clinical data management and, in brief, most commonly used medical dictionary MedDRA. The purpose of this paper is a modest contribution to easier and more successful understanding of the encoding process in clinical data management in the fi eld of pharmacovigilance. Topic: MedDRA Development, structure, multi-axiality, availability of foreign languages, as well as common problems faced by medical coding expert while coding were presented. Conclusion: MedDRA has become the standard medical terminology for drug regulators and pharmaceutical companies in Montenegro. Training should be provided to all coders in order to achieve the optimum level of coding and to ensure that all the parameters for quality are achieved. Coding should be treated as one of the most important function in clinical research.