Billev Pharma East is proud to be present at the 24th Regulatory Affairs Conference (RAC26), taking place from 26 to 27 February 2026 in Amsterdam. This event, organised by Medicines for Europe, brings together regulators, industry experts and representatives from European institutions to engage in meaningful dialogue about the evolving regulatory landscape, digital transformation, implementation of new legislative requirements and the shared goal of improving access to medicine information for patients and healthcare professionals. RAC26 provides a unique platform for collaboration, learning and forward-thinking discussion on the innovations and challenges shaping the future of regulatory science.
At the heart of this transformation is electronic product information, a topic that Billev Pharma East is deeply engaged with. In recognition of its growing importance, Katja Pečjak Reven will speak at RAC26 in Session 2: How to smoothly transition to modern ways of accessing medicine information by patients. In her session, Katja will share an in-depth perspective on electronic product information and why it is becoming a cornerstone of digital medicine information strategy — not just a regulatory requirement, but a key enabler of better access, usability and understanding for all end users. At the same time, we will be attending RAC26 as exhibitors at Stand No. 4, where our team looks forward to meeting colleagues, partners and visitors in person to exchange views on how digital transformation intersects with regulatory change in the pharmaceutical sector. These face-to-face interactions are invaluable for building connections and exploring how organisations can navigate change together.
Electronic product information refers to regulatorily approved medicine information — including the Summary of Product Characteristics, Patient Information Leaflet and labelling — adapted for electronic formats and distribution via digital platforms. As the industry moves beyond traditional managing documents, ePI offers significant advantages: structure data combined with content where information becomes accessible quickly, searchable, available in multiple languages and integrated with modern healthcare systems — all of which are essential for patients and healthcare professionals seeking reliable, up-to-date data. For Marketing Authorization Holders (MAHs), it is increasingly important to begin integrating ePI into internal processes early. If MAH waits, they’ll implement under time pressure—without stable process, tooling, and governance. By adopting ePI proactively, organisations can ensure that regulated information is not only compliant with current requirements but also ready to meet future demands of digital healthcare ecosystems. Implementing ePI well means going beyond technical standards, such as those based on Fast Healthcare Interoperability Resources (FHIR), to focus on how information is structured, presented and experienced by people. The real value of ePI lies in its practical usability — ensuring that health-related information is clear, current and truly beneficial in real-world contexts.
At Billev Pharma East, we understand that delivering effective electronic product information (ePI) goes far beyond technical implementation — it requires deep regulatory insight, content excellence and strategic digital readiness. Our team delivers a broad range of integrated services that support pharmaceutical organisations throughout the entire product lifecycle, including Regulatory Affairs, Pharmacovigilance, Medical Writing, Quality/GxP and Digital Consultancy. These capabilities enable us to not only develop technically sound ePI solutions that meet current regulatory expectations, but also to align regulatory strategy, medical content, quality assurance and digital workflows with broader organisational goals. By combining expertise across regulatory compliance, structured content authoring, and digital transformation, we help clients confidently navigate complex regulatory requirements, overcome implementation challenges and deliver meaningful, accessible information to end users in an era of rapidly evolving healthcare needs.
Beyond RAC26, this conversation continues. Katja Pečjak Reven will also present on ePI at DIA Europe 2026 on 25 March 2026 in Rotterdam, in the session “ePI for Patient Centricity and Safer Use of Medicines – from Vision to Reality”. This follow-up event further amplifies the importance of electronic product information in supporting patient-focused access to medicine information and improving safe use in the digital age.
Read also: