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Session 3: SEE Townhall Regulatory Panel
Session Chair(s)
Melly Lin, MS
CMC Regulatory Policy Lead, Pharma Technical Regulatory, F. Hoffmann-La Roche Ltd, Switzerland
Sabina Uzeirbegovic, MPHARM
Principal Regulatory Affairs Advisor, HALMED, Croatia
This session will bring together senior regulators from the SEE region, EMA and WHO. Regulators will share priorities of each country, progress of harmonization with EU regulations, experience on application of reliance. Discussion will focus on how to leverage ongoing collaboration between SEE countries and EMA, WHO to promote regulatory harmonization and facilitate the implementation of reliance to enable faster access to safe, effective, and quality medicines.
Speaker(s)
Magda Bujar, PHD, MSC
Associate Director, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Feedback from studies: Regulatory Risk-based Approaches – are these Enabling Better Availability and Access to Medicines Globally?
Srdjan Lucic
Regulatory and Policy Partner, F. Hoffmann-La Roche, Bosnia and Herzegovina
Regional Perspective on the Implementation of Reliance
Victoria Palmi-Reig, MPHARM
International Affairs, European Medicines Agency, Netherlands
Tanja Nedjic
Clinical Assessor and Digitalisation Project, Medicines and Medical Devices Agency of Serbia, Serbia
Contributing Panelist
Alija Uzunovic
Head of Control Laboratory, ALMBiH, Bosnia and Herzegovina
Contributing Panelist
Andela Draškovic
Regulatory Affairs Associate, CInMED, Montenegro
Contributing Panelist
Elena Cvetanovska
Senior Associate, MALMED, North Macedonia
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