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Nordic Regulatory Affairs Meeting

19.10.2023 09:00

Live webinar and onsite (Stockholm)

Full meeting program and speaker line up to be announced and updated continuously. The more detailed agenda and registration via Läkemedelsakademin webpage:

Online via streaming: Online

On site in Stockholm: On site 

 

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
  • Real World Evidence (RWE) in regulatory processes and in decision making Stine Hasling Mogensen, Danish 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

 

Meeting Moderators

Helena Björkman Nordic Head of Regulatory Affairs PharmaRelations AB

Henrik Fant Senior Consultant & Advisor, Regulatory Affairs Scientific Solutions

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The meeting is developed by Läkemedelsakademin AB, Sweden.

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Event time

Starts:   19.10.2023 09:00
Ends:   19.10.2023 17:05

Event location

Live webinar and onsite (Stockholm)

Wallingatan 26A
Stockholm

View larger map and directions

Contact us

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Ulla Partanen
Head of Learning Services
academy@pharmaca.fi
+358 9 6150 4973

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Sandra Trost
Project Manager
Läkemedelsakademin AB
sandra.trost@lakemedelsakademin.se

 

Organizer

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The meeting is developed by our partner Läkemedelsakademin AB, Sweden.

 

In cooperation

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