Overview

Join us at the DIA SEE (Southeastern Europe) Conference to connect and collaborate with regional, EU, and international regulatory experts. This inclusive platform allows partners to unite and discuss the harmonisation with EU regulatory systems, a key step towards EU accession.

While harmonisation requires significant work, it simplifies agency operations, facilitates reliance, and accelerates product approval for SEE patients. The conference will discuss the impact of new EU Pharmaceutical Legislation on regional regulatory systems, emphasizing quicker access and alignment with the EU framework.

Hear from SEE regulators and other major stakeholders about their challenges, future priorities, and opportunities for regional cooperation and collaboration with EU and international authorities. The conference offers a unique opportunity to learn from best practices and network with regulators and leaders from across Europe and beyond.

Featured topics

Regulatory policy of the future: convergence, reliance, and collaboration.
Increasing stakeholders’ dialogue across countries and the region.
Life-Cycle Management: Addressing lifecycle challenges, shared packs, grace period of implementation, harmonisation of change reporting with EU, and issuing of permanent Marketing Authorisations.
Digitalisation and new technologies such as e-submissions and Electronic Patient Information Leaflets (ePILs).

Featured

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Who should attend?

This conference is designed for professionals involved in:

Learning objectives

What will you gain from attending this conference? Explore the main objectives and learning outcomes below:

Understand the regulatory gap between the region and EU and how to bridge it.
Discuss the role of regulatory reliance as a catalyst for quicker access and better patient outcomes.
Promote alignment with the EU regulatory framework, as well as harmonisation of requirements and approval timelines.
Enable Health Authorities to share best practices and challenges in the region.
Network with regulators and key leaders from across Europe and beyond to increase cooperation and collaboration.

Program Committee

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)
Manuela Stojanovic-Pejovski Executive Director
Farmabrend Nova, North Macedonia
Melly Lin, MS CMC Regulatory Policy Lead, Pharma Technical Regulatory
F. Hoffmann-La Roche Ltd, Switzerland
Azira Cajic Head of Pharmacovigilance and Materiovigilance Sector
ALMBiH, Bosnia and Herzegovina
Alija Uzunovic Head of Control Laboratory
ALMBiH, Bosnia and Herzegovina
Biljana Dimitrova Advisor for Licensing and QP Manager
MALMED, North Macedonia
Mira Kontic Deputy Managing Director
Institute for Medicines and Medical Devices, Montenegro
Gordana Boljevic Stanojevic Head of the Centre for Medicines Authorisation
CInMED, Montenegro
Pavle Zelic International Cooperation, European Integrations and Public Relations
Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
Sabina Uzeirbegovic, MPharm Principal Regulatory Affairs Advisor
HALMED, Croatia (Hrvatska)