Expert Insights on the Future of ePI

Join industry leaders and regulatory experts as they share first-hand experiences and key lessons from pioneering ePI initiatives across the EU. This is a unique opportunity to learn from others who are actively shaping ePI implementation, gain insights into best practices, and explore collaborative solutions to common challenges.

The program runs from 9:00 AM to approximately 4:10 PM (EET/EEST, Finnish time). At the on-site event, you'll have the opportunity to network with colleagues, and we will offer you a light breakfast, lunch and afternoon coffee.

Program:

The times presented in the agenda are in Finnish time (EET/EEST). 

8:30 Onsite Registration Starts, Light Breakfast Available

9:00 Welcome & Practical Information
Ouli Uimonen, CEO, Pharmaca Health Intelligence
Anja Isoaho, Training Manager, Pharmaca Health Intelligence
Moderator: Mari Sirviö, Senior Advisor, Pharma Industry Finland

9:15 EU General Pharmaceutical Legislation Revision and Its Impact on ePI: Key Updates and Future Outlook
Koen Nauwelaerts, Regulatory Policy and Science Lead, Bayer

Preparing for the Future of ePL and ePI – Preliminary Experiences from Ongoing National and Nordic Projects
Nina Malvik, Senior Adviser, Norwegian Medical Products Agency (NOMA)

10:35 Break

10:55 Driving Next-Generation ePI with a Collaborative Approach Based on Structured Data
Niklas Jänich, Head of Global Labeling Operations and Digitization, Boehringer Ingelheim

Setting a Course for ePI – Estonia's Experience in the Baltics' Paperless PIL Pilot
Merit Aava, Lead of Regulatory Affairs WG, The Association of Pharmaceutical Manufacturers in Estonia (APME) & Regulatory Affairs Manager, Novartis

11:55 Lunch Break & Networking

13:05 What Is the Future Target State of ePI, and What Would the Process Look Like for the Industry and Other Stakeholders?
Hanna Saari, Service Line Lead, Associate Director, Regulatory Informatics, Cencora PharmaLex

Industry Work Towards a More Patient-Centric Leaflet Content
Christelle Anquez-Traxler, Senior Regulatory Science and Strategy Lead, AESGP

14:00 Coffee Break & Networking  

14:30 Nordic Co-operation & ePI Pilot (Gravitate Health ePI Project)
Essi Kariaho, CXO, Pharmaca Health Intelligence

Development of e-PIL in Latvia
Inese Birzule, Head of Efficacy and Safety Division & Dace Persa, Head of Distribution Authorisation Division, State Agency of Medicines of Latvia

16:00–16:10 Closing Remarks
Mari Sirviö, Senior Advisor, Pharma Industry Finland  
Anja Isoaho, Training Manager, Pharmaca Health Intelligence


Sometimes things change. Pharmaca reserves the right to make changes to the program.