The conference starts with registration at 08:30 and ends at 16:20.

Program

08:30 Registration and Breakfast

09:00 Welcome!
Ouli Uimonen, CEO, Pharmaca Health Intelligence
Anja Isoaho, Training Manager, Pharmaca Health Intelligence

09:10 Introduction to the Day
Moderators:
Henna Aalto, Regulatory Affairs Manager, Novartis Finland
Henrik Fant, Regulatory Manager, Gedeon Richter

9:20 New EU Pharmaceutical Legislation 
and Its Implications
Katarina Nedog, Director, Regulatory Policy, EFPIA

Translating the EU Pharmaceutical Legislation Reform into RA Practice: An Industry Perspective
Sini Eskola, Head of International Regulatory Policy and Innovation, Executive Director, Takeda Pharmaceuticals International

10:20 Break

10:40 Time for Questions

11:00 Patient-Oriented Solutions: English Packages and Foreign Packages

Pilot Project on English-Only Common Nordic Packages 
Cecilia Ulleryd, Head of Section, Department for Product Information, Swedish Medical Agency

Distribution of Foreign Packages
Dace Persa, Head of Distribution Authorisation Division, State Agency of Medicines of the Republic of Latvia

12:00 Lunch

13:00 Panel Discussion: "Ensuring Patient Access: Common Packs, Shortages, and Cross‑Regional Solutions" 

Key themes include:
• Common packs in the Nordics vs. the Baltics
• Addressing medicine shortages and stockouts
• Patient needs and small patient populations
• Extending pilot initiatives to Baltic countries
• Facilitating cross-border supply and importation of packs

Christer Fredlund Olsson, Head of Regulatory Affairs, North Europe Cluster, Sanofi
Dace Persa, Head of Distribution Authorisation Division, State Agency of Medicines of the Republic of Latvia
Timo Toivonen, Head, Regulatory Safety & Quality, Novo Nordisk Finland
Cecilia Ulleryd, Head of Section, Department for Product Information, Swedish Medical Agency 

14:10 Coffee Break

14:40 Pharmaca’s VNR Hub: Current Issues
Essi Kariaho, Director, Drug Information, Pharmaca Health Intelligence

15:00 How Pharmaceutical Companies Use AI in Regulatory Affairs
Juho Bah, Team Lead Regulatory Affairs, Oriola

15:45 Time for Questions

16:00 Wrap-Up Reflection
Today’s and Tomorrow’s Key Regulatory Challenges and Opportunities in the Nordics and Baltics

Moderators:
Henna Aalto, Regulatory Affairs Manager, Novartis Finland
Henrik Fant, Regulatory Manager, Gedeon Richter

16:15–16:20 Thank You!
Anja Isoaho, Training Manager, Pharmaca Health Intelligence


Stay tuned for program updates. Welcome to Helsinki in June!