Overview on the International Symposium on the Regional Regulatory Network
On 23-24 April 2009, an International Symposium on the Regional Regulatory Network was held in Priština's Grand Hotel, in organisation of the Kosovo Medicines Agency (Agjencioni i Kosovës për Produkte Medicinale, AKPM), Pharmaceutical Wholesalers Association (Shoqata e Distributorëve të Produkteve Medicinale dhe Farmaceutike të Kosovës), Pharmaceutical Association of Kosovo and the Pharmaceutical Department of the Medical School, under the auspices of the Ministry of Health of the Republic of Kosovo.The Symposium was attended by about 300 representatives of regulatory bodies, government ministries, faculties, pharmaceutical industry, pharmaceutical associations from Albania, Austria, Bosnia and Herzegovina, Bulgaria, Cyprus, Montenegro, Greece, Croatia, Italy, Canada, Macedonia, Germany, Slovenia, Sweden and Turkey.
An introductory address was delivered by Dr. Sc. Zehadin Gashi, head of AKPM, who warmly greeted and welcomed the participants at the first symposium of this kind to be held in independent Kosovo, and looked back on the Agency's past efforts. The participants were also greeted by Professor Alush Gashi, PhD, Minister of Health, who talked about the imminent health sector and legislative reform, and the Minister of Justice, Mrs. Kelmendi, followed by the chairperson of the Pharmaceutical Association, and the chairperson of the Pharmaceutical Wholesalers Association. The focus of the first day of the Symposium was on the lectures, while the second day was dedicated to the closing discussion.
During the Symposium, lectures were given, among other, by officials of the Kosovo Medicinal Agency (AKPM), Italian Medicinal Agency (Agenzia Italiana del Farmaco, AIFA), German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Ministry of Health of the Republic of Kosovo, Macedonian Institute of Public Health, Croatian Agency for Medicinal Products and Medical Devices (ALMP). Assistant Professor Siniša Tomić, PhD, head of ALMP, gave a lecture on the Croatian Regulatory System, Professor Milena Jadrijević-Mladar Takač, PhD, member of the ALMP's Committee for Medicinal Products, gave a lecture on Adverse Reactions, while Selma Arapović from the ALMP's Department of Pharmacovigilance gave a lecture on the Pharmacovigilance System in the Republic of Croatia. Also, delegates from Croatia took part as moderators of the Symposium sections, while Assistant Professor Siniša Tomić, PhD, also moderated the closing discussion.
During the symposium, the activities of the Kosovo Medicines Agency were presented, with an emphasis on restrictions, future projects, registration procedure, import and distribution of medicinal products, quality control and the pharmacovigilance system. The representatives of the Kosovo Ministry of Health emphasised the need to adjust the legal framework for import of medicines and donations, and the issues concerning distribution of medicinal products, announcing the forthcoming restructuring and establishment of the Committee for Medicinal Products and Medical Treatment and emphasising the need to create a legislative basis for proof of efficacy and safety, and to establish a correlation between costs and effectiveness. The representative of AIFA emphasised medicine availability and accessibility issues and presented a new licensing, pricing and cost reimbursement system which relies on different committees. The representative of BfArM presented simplified procedures for amendment of the marketing authorisation for the finished product, and emphasised the need to assess the need for national regulations. The role of pharmacist was emphasised on several occasions during the Symposium, and the experience of the Canadian Québec province in the area of the rational use of medicinal products was presented. Representatives of the pharmaceutical industry from Austria, Croatia and Macedonia gave an overview of the issuance process for the marketing authorisation for the finished medicinal product (Macedonian experience), advice for preparation of documents, an overview of activities related to the strengthening of the pharmacovigilance system in the European Union, while the Austrian representative pointed to the importance of the control of each series of a medicinal product, conducted by the company itself. On the second day of the Symposium, based on the experience from Bosnia and Herzegovina, a presentation was made of the importance of patient records and good pharmacist practice. Also, a poster session titled "Pharmacoeconomics and the medicines agency“, was prepared jointly by the Faculty of Pharmacy of the University of Sarajevo, Montefarm Apothecary Institution, and Galenus Pharmacy from Montenegro. In the closing discussion, some of the issues discussed included black market medicines, necessary medicinal product controls, import of medical devices, registration of the plant, dietetic and galenic preparations, as well as vitamins and minerals, problems concerning medicines distribution and the need for unequivocal legal regulations governing the issuance of the pharmacy establishment license, and the need to create the necessary legislative framework in the area of medicinal products and medical devices.
The Symposium was complemented by social events accompanied by occasional Kosovar and international pop music and an address by the head of AKPM. A welcoming reception was organised on the eve of the Symposium and the official dinner in the restaurant „Prishtine“ at the end of the first day of the Symposium. The head of AKPM, Dr. Sc. Zehadin Gashi, took the opportunity to present awards to deserving colleagues, among them to the head of ALMP, Assistant Professor Siniša Tomić. The participants were quickly carried away by the music and relaxed atmosphere and, having quickly mastered the steps, they soon joined in the kolo, which certainly added to wonderful impressions the participants took away with them upon departure from Priština.
The delegation of the Republic of Croatia had an opportunity to visit the premises of AKPM and compliment their hosts on well-equipped laboratories and the overall organisation of the Agency.
The Symposium participants together created a stimulating work atmosphere, developing an engaged discussion on current issues and presenting solution proposals. This international symposium enabled the participants to share their experience and establish contacts. The Symposium was a good stimulus for development of the future regional cooperation, thus justifying its nominal focus on the Regional Regulatory Network.
