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Session 3, Part I: Where are we now with Post-approval Changes?
Session Chair(s)
Sabina Uzeirbegovic, MPharm
Principal Regulatory Affairs Advisor
HALMED, Croatia (Hrvatska)
This session will focus on the experience from the users of the system. First from the trade associations who will provide some general reflections on the national user experience and the impact on patients. This is followed by some concrete case study examples from companies to better illustrate the broader impact of national rules in the global operational context.
Speaker(s)
Overview of common Challenges and Opportunities for the Region
Ivana Ferber, MPharm, MS
MSD, Croatia (Hrvatska)
Associate Director Regulatory Affairs; Regulatory Affairs Lead Croatia/Bosnia an
Bosnia And Herzegovina: Case Study on Manufacturing Site Changes
Lejla Rizvanbegovic-Taletovic
Sanofi d.o.o., Bosnia and Herzegovina
Regulatory Affairs Head
Bosnia And Herzegovina: Case Study on Manufacturing Site Changes
Amra Hadziabdic Deljkovic, MPharm
Novartis, Bosnia and Herzegovina
Regulatory Affairs Manager
Serbia: Case Study on Safety Label Updates
Bojan Trkulja
The Association of the Manufacturers of Innovative Drugs – INOVIA, Serbia
Managing Director
North Macedonia: Case Study on to Administrative Obstacles and Country Specific Requirements
Mirjana Ipsha-Koceva, MD
Merck Sharp & Dohme (MSD), North Macedonia
Regulatory Coordinator
Post-Approval Changes in SEE: Industry Perspective - Case Studies within the Global Context
Sylvie Meillerais, MSc
MSD Belgium, Belgium
Director Global CMC Policy
Post-Approval Changes in SEE: Industry Perspective - Case Studies within the Global Context
Winona Rei Bolislis, MA
Sanofi, France
Regulatory Science and Policy Manager
Post-Approval Changes in SEE: Industry Perspective - Case Studies within the Global Context
Gordon Byrne
Hoffmann-La Roche Ltd, Switzerland
Technical Regulatory Lead - Innovation
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