Overview
This conference is especially designed to connect regulatory and market access experts working with and/or in the South-Eastern Europe region with key regional, EU and global Leaders, including Regulators, Payers, Patients, in a neutral forum dedicated to accelerating patients’ access. We will discuss topics such as the existing access gap between the region and the EU and the importance of reliance for faster access, considering a closer alignment with the EU regulatory framework.
Back in a face-to-face format, this conference will provide a unique opportunity to learn from best practice examples and to network with regulators and key leaders from all across Europe.
Key Topics in Regulatory Affairs & Policy
- Regulatory Convergence, Reliance and Collaboration
- How to increase Stakeholders’ dialogue across countries and regions
- Regulatory flexibilities and agilities during the COVID-19 pandemic
- Digitalisation and new technologies
Key Topics in Market Access
- Exploring Innovation in Managed Entry Agreements
- Investment in healthcare: return on investment and healthy population
- Addressing inequalities and improving access to innovation
Program Committee
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Amira Deia Younes Director, Eastern Europe, Middle East & Africa (EEMEA) Global Regulatory Policy
MSD, United Arab Emirates -
Ana Petrovic Managing Director
Association of Research-Based Medicine Producers in Bosnia & Herzegovina (UIPL), Bosnia and Herzegovina -
Bojan Trkulja Managing Director
The Association of the Manufacturers of Innovative Drugs – INOVIA, Serbia -
Ivana Ferber, MPharm, MS Associate Director Regulatory Affairs; Regulatory Affairs Lead Croatia/Bosnia an
MSD, Croatia (Hrvatska) -
Jelena Simovic Regulatory Affairs Head
Janssen Pharmaceutical Company of Johnson & Johnson, Serbia -
Manuela Stojanovic-Pejovski Executive Director
Farmabrend Nova, North Macedonia -
Melly Lin CMC Regulatory Policy Lead, Pharma Technical Regulatory
F. Hoffmann-La Roche Ltd, Switzerland -
Sara Torgal, MPharm Senior Manager, Scientific Programs
DIA, Switzerland -
Samvel Azatyan, MD, PhD Team Lead, Regulatory Convergence and Networks (RCN/REG)
World Health Organization (WHO), Switzerland -
Angelika Joos, MPharm Executive Director, Global Regulatory Policy
MSD, Belgium -
Biljana Tubic, DrSc Deputy Agency Director for the Department for Medicinal Products for Human Use
Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina -
Jadranka Mirkovic Head of the Humane Medicines Centre
Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia -
Maja Lovrek Romcevic, MPharm Head of Medicines Authorisation Division
Agency for Medicinal Products and Medical Devices, Croatia (Hrvatska) -
Milena Anicic RA and QA Chapter Lead
Roche, Serbia -
Ranela Ceci, PhD Specialist, Marketing Authorization and Regulatory Affairs Department
National Agency For Medicinal Products and Medical Devices (AKBPM), Albania
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