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Plenary Session: EU General Pharmaceuticals Legislation
Session Chair(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
Ivana Ferber, MPHARM, MS
Associate Director Regulatory Affairs; Regulatory Affairs Lead Croatia/Bosnia an, MSD, Croatia
Harmonizing regulatory frameworks in non-EU SEE countries is the key to unlocking the journey to EU accession, streamlining operations, and accelerating patient access to medicines.
This session will offer a comprehensive introduction to the new EU General Pharmaceuticals Legislation within the European Union (EU) and its potential implications for EU accession countries in the South-Eastern Europe (SEE) region. The session will focus on analyzing the significant milestones in the legislation and the projected timelines for its implementation. Furthermore, it will explore the strategies for future-proofing the regulatory framework and ensuring preparedness for upcoming challenges.
The current system for post approval changes (PAC) of on market products in the region is challenging and further alignment with the EU regulatory framework is required. This session will explore the New Pharma Legislation on Variation and the new variation classification guideline.
Speaker(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
EU General Pharmaceutical Legislation and Impact on SEE Region: Legislation Milestones
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
The Proposed Revision of the EU Pharma Legislation
Alessandra Leone
CMC - Global Regulatory Sciences, Pfizer, Italy
An Update on the EU Variations Framework Revision: Reflections on the Adopted Delegated Act and Future Outlook
Erna Kasumovic
Assistant Director, Directorate for European Integration, Bosnia and Herzegovina
The Process of Harmonisation of National Legislation with the EU Acquis
Sabina Uzeirbegovic, MPHARM
Principal Regulatory Affairs Advisor, HALMED, Croatia
Contributing Panellist
Pavle Zelic
International Cooperation, European Integrations and Public Relations, Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
Contributing Panellist
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