Program

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 4:00 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.

Featured Sessions & Speakers:

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)

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

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

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

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


Stay tuned as we announce more speakers and topics soon!