Nordic Regulatory Affairs Meeting 2023

Welcome to Nordic Regulatory Affairs Meeting 2023!

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 live online 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

• Swedish presidency of the EU Council – what’s the impact for Life Science, antimicrobial resistance (AMR) and shortages of medicines? Åsa Kumlin Howell, Swedish Medical Products Agency
• EU Pharma Legislation Revision from the Authority perspective Åsa Kumlin Howell, Swedish Medical Products Agency
• EU Pharma Legislation Revision from the Industry perspective Pär Tellner, Efpia
• EU Pharma Legislation Revision from the SME perspective Anders Juréus, Regsmart Life Science AB
• Real World Evidence (RWE) in regulatory processes and in decision making Stine Hasling Mogensen, Danish Medical Products Agency
• Introduction to Nordic Cooperation Project - How it all started Ylva Satrell, Former Senior expert, Departement of Product information, Swedish Medical Products Agency
• Multilingual CP-packs - how to get Your worst case scenario multilingual pack approved Nina Malvik, Norwegian Medicines Agency
• Common Nordic packs - some examples and cases Nina Malvik, Norwegian Medicines Agency
• Norwegian e-PL pilot project Nina Malvik, Norwegian Medicines Agency

Updates from last year's meeting

• Icelandic e-PL pilot project Eva Björk Valdimarsdóttir, Icelandic Medicines Agency 
• New Veterinary Regulation Paula Kajaste, Fimea
• Radiopharmaceuticals from Regulatory Affairs Perspective Elina Krannila, Medfiles Ltd

Full meeting program and speaker line up to be announced and updated continuously. Keep track of the website!

Meeting Moderators

Helena Björkman Nordic Head of Regulatory Affairs, PharmaRelations AB

Henrik Fant Nordic Regulatory and Complience Manager, Gedeon Richter

Time and venue

The meeting is held Oct 19, 2023 at 09:00 am to 17:05 pm online and on site at Apotekarsocieteten, Wallingatan 26A in Stockholm.

If you want to participate on site in Stockholm, register via this link: On site