News and Educations

Overview of the International Conference „Communicating the Risk in Pharmacovigilance-Are We Going in the Right Direction?“

On 1-2 October this year, in Hotel Kolovare in Zadar, a two-day international conference „Communicating the Risk in Pharmacovigilance-Are We Going in the Right Direction?“, co-organised by the Croatian Agency for Medicinal Products and Medical Devices (ALMP) and the Croatian Pharmaceutical Society (HFD) was held under the auspices of the Croatian Ministry of Health and Social Welfare. This conference is the fifth professional conference on pharmacovigilance organised by the ALMP.

During the opening, the participants were addressed by Head of the Agency for Medicinal Products and Medical Devices, Assist. Prof. Siniša Tomić, PhD (Speech of the Head of the ALMP), President of the Croatian Pharmaceutical Society Krešimir Rukavina, MPharm and Dr. Dražen Grgurović, Deputy Mayor of the City of Zadar.

Lectures were given by prominent experts from the WHO Collaborating Centre for International Drug Monitoring, competent authorities from the EU Member States (Belgium, Ireland, German, Great Britain), ALMP, countries of the region (Macedonia, Serbia) and pharmaceutical industry associations. The topics were primarily linked to the role and responsibility of regulatory authorities and the pharmaceutical industry in transfer of information concerning the risk associated with use of medicinal products. Any new knowledge about risk associated with certain medicinal products has to be efficiently passed on to healthcare professionals and patients, i.e. those who prescribe and those who use the products in question. It was pointed out that any changes in safety information have to be made available as quickly as possible to healthcare professionals who can promptly inform their patients and take this information into account when considering further treatment options. Throughout the conference, the emphasis was on the fact that any regulatory action has the purpose of protecting the public and individual health of the persons taking medicinal products.

On the second day of the conference, the representatives of the ALMP and the European Medicines Agency held workshops on legislation relating to the monitoring of the safe use of medicinal products in Croatia, on electronic reporting of adverse drug reactions and on introduction of safety variations in the product documentation.

The conference was attended by over 160 representatives of regulatory authorities, academia and the pharmaceutical industry. The goal was to enhance the cooperation between the Croatian and the European experts in communication of pharmacovigilance risks and exchange of views, insights and experience in this field. The conference was therefore extremely important for the process of monitoring medicines safety in the Republic of Croatia.

The interview with the Head of the Agency, Assist. Prof. Siniša Tomić, PhD, about various aspects of the conference, can be seen at the link below:

The press release from the conference can be seen here.

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Overview of the International Conference „Communicating the Risk in Pharmacovigilance-Are We Going in the Right Direction?“