Nordic Regulatory Affairs Meeting 2025

About the meeting

Nordic Regulatory Affairs Meeting 2025 brings the Nordic authorities and pharmaceutical industry operators together on the latest news about the hottest topics discussed within Regulatory Affairs.

Who should attend?

Professionals with an interest in Regulatory Affairs in the Nordics. We welcome participants from pharmaceutical companies, pharmaceutical industry associations, national competent authorities, contract research organizations, consultants and academia.

Gather Your regulatory team and invest this full day in Your professional development! Meet representatives from the authorities and industry and expand Your Regulatory network within the Nordic region.

Register today!

Highlights from the agenda

  • Updated EU variation guideline Authority perspectiveHanna Holst, Swedish Medical Products Agency and Natascha Johansen, Norwegian Medical Products Agency
  • Updated EU variation guideline Corporate perspectiveSini Eskola, Takeda
  • Joint Nordic project with English language patient information leaflets Cecilia Ulleryd, Swedish Medical Products Agency
  • AI in Regulatory Affairs Authority perspective –  REGULUS, the newly launched internal MPA generative AI system to support assessors – Samuel Fransson and Sofia Bosdotter Enroth, Swedish Medical Products Agency
  • AI in Regulatory Affairs Corporate perspective Insights into the effectiveness of using AI to draft and manage eCTD submissions – from a digital innovation and CMC perspective – Harry Rowland, Business Partner Regulatory, Digital Innovation, PharmaLex
  • PICs new VNR hub – a practical demo of new and coming functionalities– Riikka Manninen, Pharmaca Health Intelligence
  • Current issues on the availability of medicines Riikka Holthöfer, Fimea

Speakers

Helena Björkman
Pharma Relations
Henrik Fant
Gedeon Richter
Hanna Holst
Läkemedelsverket/Swedish Medical Products Agency
Cecilia Ulleryd
Läkemedelsverket/Swedish Medical Products Agency
Harry Rowland
PharmaLex
Natascha Johansen
Norwegian Medical Products Agency
Samuel Fransson
Läkemedelsverket/Swedish Medical Products Agency
Sofia Bosdotter Enroth
Läkemedelsverket/Swedish Medical Products Agency
Riikka Manninen
Pharmaca Health Intelligence
Riikka Holthöfer
Fimea

Sponsors

                        

 

 


 

Interested in logo visibility at Nordic Regulatory Affairs Meeting 2025?

  • Contact: Lena Berlin

 


The Nordic Regulatory Affairs Meeting is arranged by Läkemedelsakademin 2025. Next Nordic Regulatory Affairs Meeting is arranged by Pharmaca, Finland. Date to be communicated.

Contact us

Lena Berlin
Administrator. For questions about registration.
Sandra Trost
Director of Continuing Professional Development. For questions about course content and large orders.

Upcoming meeting

Date: October 1

Price:
4700 SEK, early registration fee 1 – 4 participants before Sep 1
4400 SEK, early registration fee 5 participants and more before Sep 1

5400 SEK, late registration fee 1 – 4 participants after Sep 1
5000 SEK, late registration fee 5 participants or more after Sep 1

Price excluding VAT

Venue: Carolina Tower, Hagastaden, Stockholm

Language:  English

Registrations terms

 

Registration