Nordic Regulatory Affairs Meeting brings the Nordic authorities and pharmaceutical industry operators together on the latest news about the hottest topics discussed within Regulatory Affairs.

Updated EU variation guideline - Authority perspective 
Hanna Holst, Swedish Medical Products Agency 
Natascha Johansen, NOMA

Corporate perspective 
Sini Eskola, Takeda

Joint Nordic project with English Patient Leaflets (PLs) 
Cecilia Ulleryd, Swedish Medical Products Agency

Icelandic ePL project – an update 
Gunnbjört Þóra Sigmarsdóttir, Icelandic Medicines Agency

The Regulatory Affairs role 
How it all started…until now and forward…
Thomas Fockter, Balder Pharma

AI in Regulatory Affairs 
Authority perspective – REGULUS, the newly launched internal MPA generative AI system to support our assessors 
Samuel Fransson and Sofia Bosdotter Enroth, Swedish Medical Products Agency

Corporate perspective - Insights into the effectiveness of using AI to draft and manage eCTD submissions – from a digital innovation and CMC perspective 
Harry Rowland, PharmaLex

The VNR hub 
Practical demo of new and coming functionalities 
Riikka Manninen, Pharmaca Health Intelligence

Current issues on the availability of medicines 
Riikka Holthöfer, Fimea

Meeting wrap-up reflection
Today’s and tomorrow’s most important regulatory challenges – and opportunities in the Nordics?
Helena Björkman, Avia Pharma, Henrik Fant, Gedeon Richter, Elisabeth Grandin, Swedish Medical Products Agency, Cecilia Ulleryd, Swedish Medical Products Agency