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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 (Hrvatska)
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)
Feedback from studies: Regulatory Risk-based Approaches – are these Enabling Better Availability and Access to Medicines Globally?
Magda Bujar, PhD, MSc
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Senior Manager, Regulatory Programme and Strategic Partnerships
Regional Perspective on the Implementation of Reliance
Srdjan Lucic
F. Hoffmann-La Roche, Bosnia and Herzegovina
Regulatory and Policy Partner
Victoria Palmi-Reig
European Medicines Agency, Netherlands
International Affairs
Contributing Panelist
Tanja Nedjic
Medicines and Medical Devices Agency of Serbia, Serbia
Associate in SwPC, Pil and labelling Unit
Contributing Panelist
Alija Uzunovic
ALMBiH, Bosnia and Herzegovina
Head of Control Laboratory
Contributing Panelist
Andela Draškovic
CInMED, Montenegro
Regulatory Affairs Associate
Elena Cvetanovska
MALMED, North Macedonia
Senior Associate
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