Billev Pharma East at RAC26: driving regulatory affairs for pharmaceutical industry innovation

In a period marked by significant shifts in the European pharmaceutical regulatory framework, the role of regulatory affairs for pharmaceutical industry has never been more critical. Following the recent conclusion of major revisions to EU pharmaceutical legislation, the industry faces several years of implementation, adaptation and digital transformation -requiring companies to rethink regulatory strategy not only as a compliance function, but as a core business enabler.

The 24th Medicines for Europe Regulatory Affairs Conference (RAC26), held on 26–27 February 2026 in Amsterdam, served as a pivotal forum where regulators, industry leaders, policymakers and subject matter experts convened to exchange insights and prepare for the numerous regulatory changes shaping the future of medicines across Europe. Participants explored legislative updates, digitisation, new regulatory responsibilities, lifecycle approaches and environmental considerations that are now part of the evolving regulatory landscape.

Why regulatory affairs for pharmaceutical industry matters now

The pharmaceutical sector is undergoing one of the most transformative periods in regulatory history, with the recently agreed EU pharmaceutical legislation setting a foundation for future compliance and market practices. This new regulatory environment places increasing emphasis on digital readiness, quality systems, product information accessibility and streamlined lifecycle management, all of which are core to the modern interpretation of regulatory affairs for pharmaceutical industry.

At RAC26, one of the recurring themes was how companies can turn regulatory obligations into strategic advantages. Central questions explored included how to implement revised variations regulations and transition toward modern patient-centric access to product information — trends that reinforce the growing strategic importance of regulatory affairs as an integrated function supporting business resilience and growth.

From strategy to practice: how Billev Pharma East supports regulatory affairs needs and digital transformation, including electronic product information implementation

Participation at RAC26 underscored a central truth: regulatory affairs for pharmaceutical industry is now inherently linked with strategic planning, digital readiness and lifecycle governance. Billev Pharma East is positioned to support companies in navigating this complexity with a comprehensive, integrated service model grounded in deep regulatory expertise and practical experience.

Our approach begins with a tailored regulatory strategy that aligns with both current EU requirements and future regulatory trends. We help organisations translate regulatory obligations into clear, executable plans — from early engagement with authorities and dossier preparation, through to submission management, lifecycle activities and product information readiness.

Beyond regulatory strategy, our work spans pharmacovigilance, ensuring robust safety monitoring and compliance across the product lifecycle; medical consultancy and medical writing, where high-quality clinical and regulatory documentation supports submissions and ongoing compliance.

In response to the growing digital emphasis in regulatory processes, we also provide targeted support in digital consultancy, especially around implementation of electronic product information and data integrity frameworks — bridging the gap between regulatory requirements and digital execution.

Billev Pharma East at the 24th Medicines for Europe Regulatory Affairs Conference (RAC26)

Billev Pharma East was proud to participate in RAC26 both as an exhibitor and as an active contributor to the conference programme. Our presence in Amsterdam allowed our team to engage directly with regulatory authorities, industry peers and thought leaders, sharing perspectives and practical approaches that link regulatory strategy with effective implementation in real-world settings.

At our exhibition stand, we welcomed numerous visitors keen to discuss the implications of regulatory reform, digital transformation and evolving compliance expectations. Conversations ranged from product lifecycle optimisation to advanced digital product information strategies, reinforcing the holistic role that regulatory affairs plays in the pharmaceutical landscape.

Katja Pečjak Reven on Modern Access to Medicine Information 

A highlight of the event was the participation of Katja Pečjak Reven, M.Sc. Pharm., Head of Regulatory Affairs and Industry Subject Matter Expert for EMA/HMA ePI Project, who was invited to speak in Session 2: “How to smoothly transition to modern ways of accessing medicine information by patients?” Katja’s contribution provided a forward-looking perspective on “Transition to ePI as a New Way of Accessing PI”. Key considerations for managing the transition from current practices to the new model, including realistic timelines and stakeholder impact. electronic product information (ePI) is not only a format change—it is a regulated, lifecycle-managed digital asset. Delivering it safely and consistently requires joint governance, interoperable systems, and coordinated change management across the EU regulatory network and Industry.

Insights from RAC26: navigating the Future of Regulatory Affairs for pharmaceutical industry

The RAC26 programme was rich with content directly relevant to companies navigating regulatory complexity. Sessions addressed the implementation of revised EU pharmaceutical legislation, the interplay between horizontal and medicine-specific regulations, and the broader effects of changing regulatory responsibilities on market access and competitiveness.

Conference discussions also covered the implications of updated variation regulations, the anticipated coexistence of Active Substance Master File (ASMF) pathways with existing certification schemes, and approaches to streamline regulatory submissions and reporting. These topics highlighted how regulatory affairs must evolve to integrate digital tools, data interoperability and lifecycle processes that extend far beyond traditional submission pathways.

Looking ahead: trends in regulatory affairs for pharmaceutical industry

The forward-looking discussions at RAC26 underline that regulatory affairs for pharmaceutical industry is evolving rapidly. As companies prepare for new regulatory responsibilities, enhanced digital reporting and more transparent lifecycle management, there is increasing demand for partners who can provide cohesive strategic guidance and operational support across a broad spectrum of compliance domains.

Billev Pharma East remains committed to helping clients anticipate change, implement solutions effectively, and leverage regulatory insight for competitive advantage. Our engagement at RAC26 reflects not just our industry involvement, but our dedication to translating regulatory evolution into practical, value-driven outcomes — for our clients and the patients they serve.