Billev Pharma East Shares Electronic Product Information Expertise as Pharmaceutical Industry Embraces Digital Transformation

Ljubljana, Slovenia: As the pharmaceutical industry undergoes a fundamental digital transformation, regulatory affairs specialists Billev Pharma East demonstrated its pioneering role in electronic product information (ePI) implementation at the Global Pharmaceutical Regulatory Affairs Summit in Berlin.

With direct participation in the European Medicines Agency’s ePI pilot project since 2022, Katja Pečjak Reven, Owner and Head of Regulatory Affairs at Billev Pharma East and a recognized expert in the ePI field, presented practical insights across two days at the Global Pharmaceutical Regulatory Affairs Summit, showcasing how companies can successfully navigate the transition from traditional paper-based product information to dynamic digital formats.

Turning digital transformation into competitive advantage

Over the course of the Summit, she served as a featured speaker on two occasions. On October 21, 2025, she presented on Regulatory Information Management and Digital Transformation, providing a Service Update & Product Management Service. Two days later, on October 23, she delivered an industry case study on Experiences with ePI within the Global eSubmissions track.

Drawing from Billev’s direct involvement as a participant in the EMA’s ePI pilot project, Katja Pečjak Reven shared an industry case study demonstrating how ePI can:

• Improve the accuracy and currency of product information.
• Reduce update cycle time across markets.
• Enable digital access for patients and HCPs while preserving compliance and version control.

Billev’s methodology translates the regulatory requirement for ePI from a compliance obligation into a strategic operational advantage. By integrating electronic product information with regulatory information management (RIM) systems, data standards, and IDMP alignment, companies can build repeatable, scalable processes that support both immediate regulatory needs and long-term digital transformation goals.

“Our goal is to turn regulatory change into operational advantage,” said Katja Pečjak Reven. “When ePI, RIM, and data standards are aligned, companies gain both regulatory confidence and measurable efficiency.”

Proven ePI expertise – from pilot project to business transformation

Billev’s presentations emphasized practical, actionable guidance for pharmaceutical companies preparing for the phased implementation of ePI across the EU. With the EMA planning to begin with voluntary adoption for centrally authorized products in 2025, followed by progressive expansion to nationally authorized products, companies need to understand how to structure their content, systems, and processes for this digital future.

At Billev Pharma East, the focus is on helping companies ensure that digital transformation delivers lasting results. True success goes beyond adopting new technologies – it requires updated governance, clearly defined roles, robust data management, and effective tools. The company supports organizations in building sustainable ePI capabilities that strengthen the entire product information lifecycle.

Billev’s electronic product information services

Billev Pharma East supports pharmaceutical companies throughout their electronic product information journey, from initial strategy through full-scale implementation:

ePI strategy and roadmap development – assessment of current capabilities, gap analysis, and phased implementation planning.

Content modeling and governance – establishing frameworks for structured content creation and lifecycle management.

PLM Portal guidance and training – supporting companies in accessing and using the EMA’s ePI authoring tools, and integrating ePI workflows with their internal regulatory information management systems.

EU ePI Common Standard compliance – ensuring alignment with FHIR-based requirements and data standards.

Pilot-to-scale transformation – leveraging lessons learned to build enterprise-wide ePI capabilities.

Regulatory information management integration – connecting ePI with RIM systems and IDMP requirements.

Quality assurance and validation – ensuring electronic product information meets regulatory expectations.

“Digital transformation in pharmaceutical product information is inevitable and accelerating,” Pečjak Reven explained. “Companies that approach ePI strategically – viewing it as an opportunity to modernize their entire regulatory information ecosystem – will gain significant competitive advantages in speed, quality, and compliance. That’s the value Billev brings: deep regulatory expertise combined with practical implementation experience from the EMA pilot project.”

About Billev Pharma East

Headquartered in Ljubljana, Slovenia, Billev Pharma East Ltd is a specialist consultancy supporting pharmaceutical, veterinary, and medical devices companies in bringing safe, effective, and compliant products to market. Drawing on decades of regulatory, quality, and inspection experience at both industry and authority levels, Billev provides expert guidance through every stage of development — from early strategy to post-market oversight — in alignment with EU and global requirements.

Operating under its founding vision “One Partner. Comprehensive Solutions”, Billev integrates services across regulatory affairs, pharmacovigilance, veterinary pharmacovigilance, quality and GxP compliance, GMP consulting and batch release, medical writing, and digital transformation. This unified model ensures seamless collaboration, faster approvals, and a coherent pathway from development through to market launch.

The company’s multidisciplinary portfolio also extends to medical device compliance, including ISO 13485 consulting, MDR/IVDR implementation, and QMS auditing, alongside Qualified Person (QP) batch release services and support for electronic product information and data integrity validation. Its consultants work closely with clients to align technical, regulatory, and strategic goals across product lifecycles.

Quality is central to Billev Pharma East’s operations. The company holds multiple certifications, including MIA & GMP certification for importation and batch release, ISO 9001:2015, and ISO 13485:2016, and employs certified GMP, GDP, and GCP auditors as well as lead auditors for medical devices quality systems. This commitment to excellence underpins every consultancy service and reinforces Billev’s reputation as a trusted, compliant partner.

Founded in 2007, Billev Pharma East has grown under the leadership of Dr. Sebastjan Reven, whose background includes senior regulatory authority roles, such as Head of the Pharmaceutical Inspection Division of the Slovenian competent authority. Today, the company combines regulatory insight with industry pragmatism to serve clients across Europe and selected global markets through an experienced international consultant network.

More information is available at: https://billeveast.com/

About the Global Pharmaceutical Regulatory Affairs Summit 2025

The Global Pharmaceutical Regulatory Affairs Summit (GPRAS) is an annual expert-level forum helping companies and consultants optimize regulatory information management (RIM) and common technical document (CTD) preparation, guided by insights from competent authorities and seasoned industry professionals.

The 2025 GPRAS, held over three days from October 21 at the Hotel Palace Berlin, focused on IDMP, RIM, and Global eSubmissions. Conference tracks included Regulatory Information Management and Digital Transformation, IDMP Implementation, EU Pharmaceutical Package and Legislative Updates, The Future of eCTD, AI and Technology in Regulatory Affairs, and Data Management and Standardization.

The event was organized by Informa Connect. More details: https://informaconnect.com/global-pharmaceutical-regulatory-affairs/

Resources

Click on Electronic product information: driving the future of digital healthcare communication for ePI insights from Billev Pharma East.