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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)
Feedback from studies: Regulatory Risk-based Approaches – are these Enabling Better Availability and Access to Medicines Globally?
Associate Director, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Regional Perspective on the Implementation of Reliance
Regulatory and Policy Partner, F. Hoffmann-La Roche, Bosnia and Herzegovina
Victoria Palmi-Reig, MPHARM
International Affairs, European Medicines Agency, Netherlands
Contributing Panelist
Clinical Assessor and Digitalisation Project, Medicines and Medical Devices Agency of Serbia, Serbia
Contributing Panelist
Head of Control Laboratory, ALMBiH, Bosnia and Herzegovina
Contributing Panelist
Regulatory Affairs Associate, CInMED, Montenegro
Elena Cvetanovska
Senior Associate, MALMED, North Macedonia
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