Within the framework of the activities of the project “Harmonization of the Albanian Pharmaceutical Legislation with the European Pharmaceutical Directive” (PHARM-EU), part of the Jean Monnet Module actions funded by the European Union’s Erasmus+ programme, the conference entitled “The Current State of Pharmacovigilance in Albania: Challenges and Perspectives” was held on April 8, 2026, at 11:00 a.m., in Room B105 of the Catholic University “Our Lady of Good Counsel”.
The event was moderated by the scientific organizer of the conference and coordinator of the PHARM-EU project, Assoc. Prof. Malvina Hoxha, who emphasized the importance of pharmacovigilance as a fundamental tool for ensuring drug safety and protecting public health, while also highlighting the need for continuous alignment with European standards.
The Dean of the Faculty of Pharmacy, Prof. Roberto Perrone, emphasized the central role of pharmacists in the pharmacovigilance process, particularly in reporting adverse drug reactions and monitoring drug safety in everyday practice.
Among the speakers, Jovisa Marku, Pharmacovigilance Specialist at the Albanian Agency for the Control of Medicines and Medical Devices (AKBPM), involved in pharmacovigilance activities including adverse drug reaction reporting, and signal management presented recent developments in pharmacovigilance in Albania, with particular focus on the legislative framework and regulatory updates.
Dr. Hedie Haxhiu, Regulatory Affairs Specialist responsible for the preparation, maintenance, and updating of CTD for medicines produced by Profarma in compliance with national and international legislation, highlighted reporting procedures and the importance of accurate and timely notification of adverse drug reactions.
Dr. Dorina Haruni, medical representative of the Menarini office in Albania, illustrated the practical aspects of adverse drug reaction reporting forms, emphasizing the importance of accurate data collection in clinical practice.
The conference concluded with a lively discussion between participants and the panel of speakers, during which the main current challenges of the pharmacovigilance system in Albania and possible future perspectives were addressed.
