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Talk Global Insights track

S0410 - South East Europe (SEE) Townhall: Modernization of Regulatory Framework through Digitalization, Harmonization, and Reliance

Wed, Mar 19, 2025 · 4:50–6:00 PM CET Shanghai 1-2 Room, Congress Center Basel

About this session

This session unites non-EU SEE regulators in sharing regional successes and best practices in harmonising with EU legislation, reliance implementation and digital tools utilisation. It will also highlight the collaboration between the SEE and EU regulatory authorities, including key highlights from the DIA SEE 2024 Conference, and progress made towards aligning with the EU regulatory framework.

Programme:
- 2. Regulatory Framework through Digitalization, Harmonization, and Reliance. — Marko Eric
- 1. Setting the scene — Ivana Ferber
- 4. Panel Discussion — Victoria Palmi
- 3. Regulatory Framework through Digitalization, Harmonization, and Reliance — Marija Trajchuleski

Speakers

  • Marija Trajchuleski

    Head of sector for evaluation of the documentation for marketing authorization for medicines and medical devices · Agency for medicines and medical devices (MALMED)

    Speaker

  • Victoria Palmi

    Senior International Affairs Officer · European Medicines Agency

    Panelist

  • Ivana Ferber

    Associate Director Regulatory Affairs, MSD, · Merck Sharp & Dohme

    Chair

  • Marko Eric

    Human Medicinal Products Regulatory Affairs Digitalisation Project · Medicines and Medical Devices Agency of Serbia

    Speaker

  • Melly Lin

    CMC Regulatory Policy · F. Hoffmann-La Roche Ltd

    Chair