DIA Workshop on Optimising Variations Regulatory Framework Zagreb, Croatia

This Workshop, focused on the South East European and EU accession countries, aims to provide a platform for discussion on how to optimize the regulatory framework for variations to facilitate the uninterrupted product supply to patients, by bringing together Health Authorities, Trade Associations and Pharmaceutical Industry representatives, amongst other stakeholders.

  • Update on the EU variation legislation and expected developments under ICH Q12
  • Insights into managing variations in South East Europe and EU accession countries
  • Discussion on how to optimize the post-approval framework for variations to facilitate uninterrupted product supply to patients
  • Meet Health Authorities and Industry Leaders from EU countries and South Eastern Europe non-EU countries

Targeted audience
This workshop will benefit professionals working in the field of Regulatory Science, Regulatory Strategy, and health
authority professionals working in Regulatory Networks and Regulatory Harmonization.