Billev Pharma East – Your Partner for Pharmacovigilance Success at EUPV Congress 2025

Ljubljana, Slovenia: Billev Pharma East, pharmacovigilance service provider will attend the 2025 European Pharmacovigilance (EUPV) Congress in Milan (28 November, in-person) and online (19–20 November). To strengthen professional networks, share insights on responsible AI implementation, and discuss practical solutions to the industry’s most pressing pharmacovigilance challenges.

The Congress arrives at a pivotal moment for drug-safety teams. AI-enabled workflows, rising quality expectations for safety databases, advanced signal detection, modernization of PV systems and new EU pharmacovigilance legislation expected in 2026 are prompting companies to fundamentally reassess the robustness, compliance, and scalability of their PV operations. Billev Pharma East, as pharmacovigilance expert, is actively helping organizations transform challenges in pharmacovigilance into opportunities, building stronger, more efficient, and inspection-ready safety systems that meet tomorrow’s standards today.

Companies with a small portfolio of human medicinal products often find it more practical to opt for pharmacovigilance outsourcing, as this approach helps reduce operational costs while still meeting regulatory expectations. External partners can ensure uninterrupted service regardless of staff changes or workload fluctuations, providing stable business continuity. In addition, outsourced teams typically maintain up-to-date expertise through continuous training and exposure to a wide range of products and regulatory environments, which can be challenging for smaller organizations to sustain internally.

Quality of Reports on Drug Toxicity in Eudravigilance

Recent research by Billev’s Jana Brajdih Čendak, Medical and Pharmacovigilance Lead, highlights the importance of high-quality data in pharmacovigilance. Her study “Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective,” published in Therapeutic Innovation & Regulatory Science (2025), examines the quality of individual case safety reports in EudraVigilance, emphasizing the critical role of complete and accurate information in effective signal detection and safety assessment.

Pharmacovigilance and AI – Evolving Foundations Requiring Expert Guidance

As pharmacovigilance enters a new era of AI integration, companies face critical considerations around validation, human oversight, data integrity, and regulatory compliance. The convergence of pharmacovigilance and AI presents both unprecedented opportunities and complex challenges in pharmacovigilance that require experienced guidance to navigate successfully.

Across the industry, pharmacovigilance teams are navigating a period of rapid transformation. AI tools promise faster case intake, improved triage and prioritisation, and earlier recognition of complex safety patterns through enhanced signal detection capabilities. However, they introduce new considerations around validation, auditability, data integrity, and the expanded role of the QPPV in overseeing automated workflows.

Proven Pharmacovigilance Expertise

The company is an active member of ISOP (International Society of Pharmacovigilance), leading the ISOP Special Interest Group on ATMPs and Radiopharmaceuticals, and is also an active member of the Medicines for Europe Pharmacovigilance Working Group, maintaining strong connections to the international PV community and staying at the forefront of regulatory and scientific developments in drug safety.

As pharmacovigilance vendor, Billev Pharma East successfully guides organisations through comprehensive, end-to-end pharmacovigilance services that combine regulatory expertise with operational excellence:

• Implementation and maintenance of a robust Pharmacovigilance System Master File PSMF).
• Qualified Person for Pharmacovigilance (QPPV) services with medical adviser support (24/7 availability).
• Collecting and reporting adverse drug reaction report(s).
• Signal detection and signal-management processes supported by strong scientific and regulatory insight, with proven methodologies that satisfy both internal quality standards and external inspections.
• EudraVigilance and global safety-database management, ensuring data quality and compliance across multiple jurisdictions.
• PV system governance, pharmacovigilance audit, gap analyses, and inspection readiness programs that identify vulnerabilities before regulators do.
• Preparation of Periodic Safety Update Reports (PSURs).
• Development of a tailored pharmacovigilance risk management plan (RMP) in pharmacovigilance.
• Benefit-risk assessment.
• Comprehensive PV trainings.

While advanced technologies can accelerate pharmacovigilance, Billev emphasises that human expertise – particularly medical assessment, contextual interpretation, and benefit–risk judgement – remains central to what is patient safety. The company’s approach balances innovation with the proven fundamentals of signal detection and pharmacovigilance that have sustained drug safety for decades.

Preparing Clients for 2026 Regulatory Requirements

The anticipated 2026 update to EU pharmacovigilance legislation is expected to introduce significant new requirements in areas such as data governance, transparency, system validation, and QPPV responsibilities.

Billev Pharma East brings extensive experience in interpreting emerging regulations and translating them into practical, compliant, and durable PV operations. The company’s consultants work closely with clients to conduct readiness assessments, identify potential gaps, and implement solutions that position organizations ahead of compliance deadlines.

About Billev Pharma East

Billev Pharma East is a specialized pharmacovigilance and regulatory affairs consultancy based in Ljubljana, Slovenia. As pharmacovigilance experts, the company provides comprehensive drug safety services to pharmaceutical and biotechnology companies across Europe and globally.

With deep expertise Billev’s pharmacovigilance experts support organizations of all sizes—from emerging biotech firms to established pharmaceutical companies—in building and maintaining robust pharmacovigilance systems that comply with Good Pharmacovigilance Practice (GVP) guidelines and EU/international regulations.

For more information about Billev Pharma East’s pharmacovigilance services, visit: https://billeveast.com/ph-human-medicines/