Specialists of the Center’s Audit Department took part in the annual EMA training within the framework of the European Commission’s program “Instrument for Pre-Accession Assistance to EU Candidate Countries (IPA)”.
This time, the two-day training took place in the capital of Montenegro, Podgorica, and was devoted to harmonization with the Acquis Communautaire in the field of regulation, with a focus on the assessment of the safety and efficacy of medicinal products.
Together with our specialists, representatives of the national regulatory authorities of Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia, and Serbia took part in the training. The event was organized by the Institute for Medicines and Medical Devices of Montenegro.
During the two-day training, participants improved their knowledge of making regulatory decisions based on the assessment of the benefit-risk balance of medicinal products. They became familiar with the approaches of the Committee for Medicinal Products for Human Use (CHMP) to decision-making, examined clinical and regulatory aspects of assessing the safety and efficacy of medicines, and took part in practical workshops (case studies).
During the training, the experts worked in groups on real examples of medicinal product assessment, presented their results, and discussed approaches to improving benefit-risk assessment processes.
The knowledge gained will contribute to improving the quality of expert decisions when conducting pharmacovigilance audits, strengthening the national pharmacovigilance system, and harmonizing regulatory procedures with European requirements.
