戻る Agenda
Session 5: Ensure Uninterrupted and Secure Supply to Patients
Session Chair(s)
Amanda Tombs
Regulatory Affairs Director
AstraZeneca, United Kingdom
Pavle Zelic
International Cooperation, European Integrations and Public Relations
Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
Medicine shortages are a significant concern in various regions, including the SEE (South Eastern Europe) region. It is crucial to address these shortages as a public health issue due to the impact on patient care. In this session, senior regulators from the SEE region will share valuable insights on the causes, management, and prevention of shortages. The discussion will encompass topics such as generic interchangeability and measures to combat counterfeiting, all aimed at ensuring the availability of safe and high-quality medicines for patients. Additionally, the session will shed light on existing regulatory tools and flexibilities that can help alleviate shortages in the region. One such tool that will be shared by the industry is the concept of shared pack, which requires identical product information. This tool can be further utilized to a greater extent as we progress with reliance and establishing a predictable and aligned post-approval changes approval process across the SEE region.
Speaker(s)
Counterfeit Measures and Collaboration with EU
Pavle Zelic
Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
International Cooperation, European Integrations and Public Relations
Shortages of Medicines: Causes, Management and Prevention
Biljana Dimitrova
MALMED, North Macedonia
Advisor for Licensing and QP Manager
Medicine Shortages: Critical Medicines Act
Nick Sykes, MS
EFPIA, Belgium
Policy Advisor, Regulatory Strategy
Experience of Shared Packs: Opportunities and Challenges
Ljiljana Lupsic
Merck D.O.O., Serbia
RA Head for South Eastern Europe
Generics interchangeability
Iva Klarica Domjanovic
Medicines at Agency for Medicinal Products and Medical Devices of Croatia (HALME, Croatia
Principal Coordinator for Interchangeability
The Implementation of Regulatory Frameworks for Drug Quality Control in Bosnia and Herzegovina
Dzenana Delic
ALMBiH, Bosnia and Herzegovina
With Additional Participation of:
Alija Uzunovic
ALMBiH, Bosnia and Herzegovina
Head of Control Laboratory