Journal of Pharmacovigilance

aRMM - Croatian experience on challenges for industry to overcome

11^th International Conference and Exhibition on Pharmacovigilance & Drug Safety

June 21-22, 2018 | London, UK

Kety Mirkovic Kos

PharmaKos d.o.o, Croatia

Scientific Tracks Abstracts: J Pharmacovigil

Abstract:

Additional risk minimisation measures pose a challenge to both industry and the regulators. Applicants are obliged to actively monitor safety profile of their medicinal product and to anticipate its important safety risks, based on their own experience or information already available for originator products licensed in the EU. Croatian legislation on pharmacovigilance was last updated around the time of accession to the EU. Any further update is presented through the publicly available news section on HALMED website. Especially news concerning nationally licensed medicinal product are obliging for MAHs for Croatia. Important safety information is usually first communicated to the HCPs via DHCPs and later on in aRMM, following particular country-specific protocols. Request for common aRMM assessments is strongly supported by HALMED, with educational materials on generic name, version and HALMED approval date inserted. Approval costs for the initial aRMM materials and their update is the same, with approval timelines from 6 months to 1.5 years with tendency to decrease. Preparation of common PASS/PAESS studies may be requested by the NCA, irrespective if the licensed medicinal product is marketed in Croatia. What can the industry do to decrease costs and enhance product safety? Recent Publications 1. Kos Mirkovic K (2012) Modulation of recombinant GABAA receptors by neurosteroid dehydroepiandrosterone sulfate. Pharmacology 89:163-171. 2. Kos Mirkovic K (2001) The involvement of α2-adrenoceptors in the anticonvulsive effect of swim stress in mice. Psychopharmacology 158:87-93. 3. Kos Mirkovic K (2001) Swim stress alters the behavioural response of mice to GABA-related and some GABA-unrelated convulsants. Epilepsy Research 43:145-152. 4. Kos Mirkovic K (2000) Beta-1 adrenoceptor antagonist potentiate the anticonvulsive effect of swim stress in mice. Pharmacology Biochemistry and Behavior 67:507-510. 5. Kos Mirkovic K (2000) Anticonvulsive effect of swim stress in mice. Pharmacology Biochemistry and Behavior 66(4):879- 886.

Biography :

Kety Mirkovic Kos is a passionate multilingual pharmacovigilance and regulatory expert with comprehensive domestic and international work experience and 60+ completed courses and trainings in the fields of pharmacovigilance, regulatory affairs management, consultancy and quality assurance.