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Conferences Held
The Serbian Agency for Medicinal Products and Medical Devices has organized several professional conferences, which presents a way of informing the professional public.
2008. ----
24th November 2008, Best Western Hotel M, in Belgrade
Medicines and Medical Devices Agency of Serbia organised
„SYMPOSIUM ON BIOSIMILAR MEDICINAL PRODUCTS”
(Programme)
5th - 7th November, 2008 in Vrsac, Medicines and Medical Devices Agency of Serbia and the Association of Local Manufacturers of Medicinal Products are organising the Symposium on Bioequivalence and Bioavailability Studies – Regulatory and Practical Aspectsin
Conclusions (more details)
Results of Symposium evaluation (more details)
2007. ----
On 17 October 2007 the conference “Pharmacy and healthcare: trends and perspectives“ was held in Belgrade.
The conference program comprised of three panel discussions:
PANEL 1 Pharmaceutical legislation – national legislation and European standard
PANEL 2 Pharmacy and business
PANEL 3 Trends and standards in pharmaceutical industry
If domestic manufacturers of medicinal products do not introduce European standard of good manufacturing and distributive practice within 2 years, many of them will have to stop their production. Law on medicines has prescribed that, starting with 01 August 2009, no medicinal product of domestic manufacturers might not be in the market if it is not produced in accordance with GMP standard, worth approximately one hundred million euros.
From 31 October to 02 November 2007 in Vršac the Medicines and Medical Devices Agency of Serbia and Group of Domestic Manufacturers of Medicinal Products have organized symposium “Impurities and degradation products in pharmacy”. Professional topics, latest trends and different aspects of impurities and degradation products testing in pharmaceutically active substances and pharmaceutical products were discussed in this symposium. Relevant topics discussed in this symposium were: legislation (EU Guidelines and Directives and ICH); CEP procedure; requirements concerning impurities in registration documentation; structural determination of impurities; degradation chemistry; analysis of impurities in active substances and end products; defining the specification for impurities.
2006. ----
September 05-06, 2006 in Belgrade, European Forum for Good Clinical Practice – EFGCP from Brussels together with The Serbian Agency for Medicinal Products and Medical Devices organized conference at the highest academic level under the name "Clinical trials in Serbia – Good Clinical Practice – regulatory issues and Bioethics".
October 25-27, 2006 there was a symposium organized in Vrsac – Stability Testing of Pharmaceutical Products. Organizers of this symposium were, besides the Serbian Agency for Medicinal Products and Medical Devices, the Serbian Chamber of Commerce, that is a Group of domestic medicinal products manufacturers.
The Serbian Agency for Medicinal Products and Medical Devices (ALIMS), under the patronage of the Serbian Ministry of Health, organized a two-day meeting intended to:
- health-care workers responsible, within their health-care institutions for reporting adverse reactions to medicinal products in human medicine to the National Pharmacovigilance Centre for of the Agency, and
- holders of marketing authorization for medicinal products in human medicine, i.e. persons responsible for granting marketing authorization for medicinal products in human medicine and pharmacovigilance.
The goal of this meeting was to bring closer basic principles of pharmacovigilance, methodology of monitoring and evaluation of medicinal products safety and aspects related to the process of marketing authorization issuance.
The meeting was held on November 9 and 10, 2006, in the hall of Medifarm, Bačvanska St. n.n., Belgrade.
European conference on researches in pediatry, with particular view of pharmacotherapy with children and the development of new medicinal products, which lasted from 12th to 13th December 2006, was held in Belgrade. The conference with educational character was organized by the European Forum for Good Clinical Practice from Brussels. On the two-day conference, innovations in pediatric therapy were presented by the most eminent clinical pharmacologists, pediatrists from the EU, the USA and Israel: Prof. Rafael Gorodischer, Prof. Gerar Pons, Prof. Jonh van den Anker and dr. Klaus Rose as well as domestic experts from the domain of clinical pharmacology and pediatry Doc.dr.Milica Bajcetić, Prof dr Ida Jovanović, Doc dr.Predrag Minić, dr.Sinisa Radulović. The conference was held under the patronage of The Serbian Agency for Medicinal Products and Medical Devices and Medical Faculty in Belgrade. Guests from abroad showed the results of the newest researches of medicinal products with children which indicate that the existing practice of transferring information from clinical trials of adults to children is not enough safe and that it may have undesirable consequences. In addition, the proposal of a EU law intended for regulation of clinical trials with children and most likely to be adopted in January 2007, was presented.
2005. ----
April 11-12, 2005. The Serbian Agency for Medicinal Products and Medical Devices has organized seminar with international participation under the name of „Current Issues in Pharmaceutical Regulations”. This seminar contained two conferences – „The Fifth Edition of the European Pharmacopoeia” and „From Development of a Medicinal Product to Marketing”. Eminent European experts were lecturers on the conference: director of the European Directorate for the Quality of Medicines (EDQM), director for clinical trials and director for registration of medicinal products from Pfizer, the largest manufacturer of medicinal products in the world, experts from the British Medicinal Products Agency, director of international technologies for Europe „Kendal International”, leading world organizations for clinical trials of medicinal products (CRO), as well as independent European experts in the field of regulations regarding medicinal products.