With the European Union’s new Pharma Package turning ePI into a regulatory reality,  life science companies need to rethink how they share product information with patients and healthcare professionals.  That’s why we created the ePI Masterclass series: a hands-on, guided journey led by Anjana Pindoria-Rettenberger. Across the sessions, we meet industry experts, learn collaboratively, and work through the practical steps needed to implement ePI. If your organization needs a clear path from compliance to meaningful communication, these Masterclasses are designed to get you ready!

In the first four sessions of ePI Masterclass, we explored the questions of what ePI really means as well as where organizations should start.  A special panel discussion gave us the possibility to do so with even more industry experts. In this blog post, we take a look back on the essential insights from the first four sessions. If you have attended them, take it as a little refresher during our ePI Masterclass summer break, and if you haven't had the chance to be with us yet, we hope it makes you curious enough to register.

Remember: ePI Masterclass is free and you can join in any time. For now, we have planned sessions until the end of the year.
Please register here: https://www.extedo.com/epi-masterclass  

And now it is time to look back...

Part I: Why ePI matters, and when you need to be ready 

In this opening session, we laid the foundation for understanding ePI and its implications. We began with a clear definition of what ePI is, and equally important, what it is not. We explored its different layers, from the core content and data structures to presentation formats that make information accessible and useful. 

We examined the upstream and downstream processes that brought ePI to life and discussed how style sheets shape the way patients and healthcare professionals consume it. On the technical side, we delved into the role of FHIR standards in enabling interoperability and considered the global roadmap for ePI beyond Europe. 

By the end of this session, we had a solid understanding of ePI's foundations, technical aspects, and its role in the future of patient information. 

Part II: The Key Stakeholders in the ePI Space - Insights from the Experts 

The ePI Masterclass continued on a high note for Part II, as Anjana invited three prolific guests to a live Panel discussion. We were delighted to greet Christopher Fordham (Accord Healthcare), Dr. Niklas Jänich (Boehringer Ingelheim), and Remco Munnik (Arcana Consultancy) in the session! All of them are seasoned experts in their respective fields and look forward to sharing their professional views on ePI from different angles. Together, they explored the status as well as future opportunities, with their different perspectives on ePI, creating a complete picture.

Topics discussed were:
1. Regulatory Aspects of ePI - Authoring and Compilation 
2. Policy EU Change and Connecting to other Programmes 
3. Supply Chain/ Manufacturing and Overall Benefits 
4. AI Technology - Opportunities, Challenges, Value 


Part III:  What ePI Means for Each Stakeholder – A deep dive into different perspectives 

To understand what ePI means for each stakeholder, Anjana took us on a journey through the pharmaceutical organization. Using the labelling process as our roadmap, we visited the teams involved — from Pharmacovigilance and Regulatory Affairs to Quality, and beyond — to discover how ePI is reshaping collaboration across the product information lifecycle.  

We discovered that ePI is not confined to a single function, but a cross-functional transformation that reaches far beyond labelling and impacts the entire product information ecosystem. Beyond understanding stakeholder impacts, we left with practical insights and actionable considerations.

Part IV: The Overall Impact of ePI – ePI’s Influence on Organisations, Processes, Systems, and Skill Set​   
  
In Part IV of the ePI Masterclass, we explored what ePI means for organizations beyond the initial implementation phase. Building on the foundations established in the previous sessions, we examined the wider impact of ePI on departments, processes, systems, and the people who work with product information throughout its lifecycle.    
  
We also reviewed the latest developments in the EMA’s ePI roadmap and considered how ePI is likely to affect both upstream and downstream processes. The session highlighted that preparing for ePI is not only a matter of meeting regulatory requirements; it also calls for organizations to assess their existing capabilities, rethink ways of working, and equip their teams for change.    
  
Key topics included the impact of ePI on individual departments and systems, the challenges and opportunities it creates, and the evolving skill sets required to support a successful transition. We also discussed approaches to upskilling and the role technology can play in helping organizations manage the move toward structured, accessible, and digital product information.

Part V:  How to Prepare for ePI – Practical Insights and What to Do to Be Ready

The next session of the ePI Masterclass moved from the bigger picture to practical action.
We were pleased to welcome Mona Frimann Larsen, PhD, Founder and Principal Consultant at Vantage GmP & Labelling, as our guest lecturer for Part V. With more than 20 years of experience in life-sciences labelling and packaging, including global labelling process management at Novo Nordisk and hands-on work implementing structured labelling and ePI. Mona brings a valuable practical perspective on what ePI readiness looks like in reality.

While the previous Masterclass sessions explored what ePI is, why it matters, and how it affects stakeholders, organisations, systems, and skill sets, Part V focused on the next essential question: What should organisations do now to prepare?
Together with Mona, we discussed how to manage the organisational change that comes with ePI, where to begin upstream, and how structured content can create new possibilities downstream. The session also provided practical guidance for turning ePI requirements into sustainable processes that work across the product information lifecycle.

And ePI Masterclass goes on … 
Are you curious to learn from ePI experts how you and your organization can prepare for ePI? We invite you to join Anjana and the other experts in this unique ePI learning experience. 
Registration for the ePI Masterclass is still open, and there are some exciting and important topics to come! The sessions are free of charge, and everyone who registers will receive the recording afterwards. 

Start your ePI Masterclass experience - or continue it - and register for the remaining sessions here: https://www.extedo.com/epi-masterclass