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Session 2: Towards EU Accession
Session Chair(s)
Riccardo Luigetti
International Affairs Officer
European Medicines Agency, Netherlands
This session will provide information from Regulators in South East Europe regarding their experience with the variation system. It will shine a light on the activities that are currently under way to align their local systems in preparation for EU accession. The panel discussion will take Q&A from the audience.
Speaker(s)
Towards EU Accession – The EMA Role and Contribution
Riccardo Luigetti
European Medicines Agency, Netherlands
International Affairs Officer
Sharing post EU Accession Experience – The Croatian Regulator Perspective
Ivana Zadro, MS
Agency For Medicinal Products and Medical Devices (HALMED), Croatia (Hrvatska)
Senior Advisor - Specialist II for Validation of Applications
SEE Road to EU Accession and Alignment of Current Framework – The North Macedonian Health Authority Perspective
Elona Chilku
Agency for Medicines and Medical Devices of Macedonia (MALMED), North Macedonia
SEE Road to EU Accession and Alignment of Current Framework – The Bosnia and Herzegovina Health Authority Perspective
Biljana Tubic, DrSc
Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina
Deputy Agency Director for the Department for Medicinal Products for Human Use
Panel discussion with Q&A, with the additional participation of:
Susanne Winterscheid, PMP
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Head of Licensing Division 3
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