Zeljana Margan Koletic

Head of Pharmacovigilance and Rational Pharmacotherapy Department - Agency for Medicinal Products and Medical Devices

Zeljana Margan Koletić is Head of Department for Pharmacovigilance and Rational Pharmacotherapy at Croatian Agency for Medicinal Products and Medical Devices (HALMED) with more than 10 years of pharmacovigilance experience. She is pharmacist by training and holds a degree in clinical pharmacy. She is author of Croatian guidelines for the national approval of additional risk minimisation measures (aRMMs) and Dear Doctor Letters (DHPCs) published on HALMED's website. Together with her team, she is responsible for coordination of SAFE-CT, an EC project for increasing expertize in EU national agencies for safety assessment in clinical trials following implementation of EU CTR. She is member of HALMED's Medicinal Products' Safety Committee and since 2016 she is Croatian Alternate Member of Pharmacovigilance Risk Assessment Committee (PRAC).