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South-Eastern Europe Townhall
Session Chair(s)
Melly Lin, MS
CMC Regulatory Policy Lead, Pharma Technical Regulatory
F. Hoffmann-La Roche Ltd, Switzerland
Ivana Ferber, MPharm, MS
Associate Director Regulatory Affairs; Regulatory Affairs Lead Croatia/Bosnia an
MSD, Croatia (Hrvatska)
Non-EU SEE countries have unique and complex national regulatory frameworks and are on different status on their road map to EU accession. Harmonization with ?EU regulatory system is a hot topic across the SEE region and paves their way for EU accession. While a lot of work has to be accomplished to fully harmonize requirements and approval timelines, this investment in harmonization will not only facilitate EU accession but also enable greater reliance on EU approvals and greatly simplify and streamline agency operations. It also benefits SEE patients through faster submission and approval of products. In this session regulators from SEE will share their challenges, priorities in the coming years and opportunities for building network and cooperation in the region, and strengthening collaboration with EU and international HAs. During the panel session, we will discuss how to promote regulatory convergence towards EU and implement reliance in SEE region to accelerate patients access to new medicines.?
Speaker(s)
Sabina Uzeirbegovic, MPharm
HALMED, Croatia (Hrvatska)
Principal Regulatory Affairs Advisor
Serbia (ALIMS): Challenges, Opportunities and Priorities on Roadmap to EU
Marko Eric
Medicines and Medical Devices Agency of Serbia , Serbia
Pharmacovigilance Assessor
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
Panelist
Michiel Hendrix
EMA, Netherlands
Senior Advisor European and Global Regulatory Policy and Intelligence
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