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Hilton Garden Inn Zagreb

Jun 05, 2024 8:00 AM - Jun 06, 2024 6:00 PM

Radnicka Street 21, Zagreb, 10000, Croatia (Hrvatska)

DIA SEE (Southeastern Europe) Region Conference

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

Want to learn more about DIA SEE (Southeastern Europe) Region Conference? You've come to the right site!

Continuing Education

Exhibits

Who should attend?

This conference is designed for professionals involved in:

  • Regulatory Affairs
  • Regional Regulatory Development
  • Regulatory Submissions
  • Policy & Intelligence
  • Patient Engagement
  • Patient Advocates
  • Health Authorities
  • EU Integration office
  • Pharmacovigilance
  • Patient (patient journey/perspective)

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
    Ana Petrovic Managing Director
    Association of Research-Based Medicine Producers in Bosnia & Herzegovina (UIPL), Bosnia and Herzegovina
  • Bojan  Trkulja
    Bojan Trkulja Managing Director
    The Association of the Manufacturers of Innovative Drugs – INOVIA, Serbia
  • Ivana  Ferber, MPharm, MS
    Ivana Ferber, MPharm, MS Associate Director Regulatory Affairs; Regulatory Affairs Lead Croatia/Bosnia an
    MSD, Croatia (Hrvatska)
  • Manuela  Stojanovic-Pejovski
    Manuela Stojanovic-Pejovski Executive Director
    Farmabrend Nova, North Macedonia
  • Melly  Lin, MS
    Melly Lin, MS CMC Regulatory Policy Lead, Pharma Technical Regulatory
    F. Hoffmann-La Roche Ltd, Switzerland
  • Azira  Cajic
    Azira Cajic Head of Pharmacovigilance and Materiovigilance Sector
    ALMBiH, Bosnia and Herzegovina
  • Alija  Uzunovic
    Alija Uzunovic Head of Control Laboratory
    ALMBiH, Bosnia and Herzegovina
  • Biljana  Dimitrova
    Biljana Dimitrova Advisor for Licensing and QP Manager
    MALMED, North Macedonia
  • Mira  Kontic
    Mira Kontic Deputy Managing Director
    Institute for Medicines and Medical Devices, Montenegro
  • Gordana  Boljevic Stanojevic
    Gordana Boljevic Stanojevic Head of the Centre for Medicines Authorisation
    CInMED, Montenegro
  • Pavle  Zelic
    Pavle Zelic International Cooperation, European Integrations and Public Relations
    Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
  • Sabina  Uzeirbegovic, MPharm
    Sabina Uzeirbegovic, MPharm Principal Regulatory Affairs Advisor
    HALMED, Croatia (Hrvatska)

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