Billev Pharma East Study Calls for Enhanced Pharmacovigilance to Strengthen Drug Safety

Ljubljana, Slovenia: A new peer-reviewed study by Dr. Jana Brajdih Čendak, Medical and Pharmacovigilance Lead and QPPV at Billev Pharma East, identifies significant shortcomings in the quality and completeness of adverse drug reaction reports in EudraVigilance, highlighting the importance of strong pharmacovigilance practice.

The study, Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective, by Dr. Jana Brajdih Čendak was published in the peer-reviewed journal Therapeutic Innovation & Regulatory Science and demonstrates the high level of scientific rigor the company applies to pharmacovigilance practice and client programmes.

High-Level Expertise

Jana Brajdih Čendak is currently undertaking the Postgraduate Toxicology Course at the Medical University of Vienna – a comprehensive programme covering pharmaceuticals, industrial chemicals, pesticides, food and water safety, clinical and forensic toxicology, and ecotoxicology.

Improved Pharmacovigilance Needed Across Reporting Systems

The study aimed to evaluate the quality of adverse drug reaction report(s) and identify pharmacovigilance system improvements that could reinforce patient safety. Jana analysed 500 individual case safety reports (ICSRs) from the EudraVigilance database (2015–2024) across five widely used substances – paracetamol, diazepam, fentanyl, quetiapine, and fluoxetine—using a structured scoring framework covering drug identification, temporal data, medical history, narrative quality, and assessment of suspect vs. concomitant drugs.

The analysis revealed an average score of 11.57/25, indicating significant deficiencies in information completeness. Common issues included missing dosage and regimen details, inadequate timing information, incomplete patient history, and unclear attribution of suspect drugs. Reports originating outside the EEA and those submitted by consumers showed notably lower quality. These gaps can limit the usability of reports for timely signal detection and undermine compliance with PV requirements.

Such inconsistencies undermine signal detection, delay benefit–risk assessment and place a heavier burden on pharmacovigilance teams.

Expert Recommendations and Implications for Industry Practice

The results underscore the importance of systematic pharmacovigilance audit, improved training for reporters, and structured follow-up of incomplete ICSRs. The study also highlights the critical need for clear roles and responsibilities in pharmacovigilance outsourcing —particularly around QPPV accountability – to ensure data quality and regulatory compliance.

These findings align with the areas Billev Pharma East supports through structured ICSR case management, pharmacovigilance audits, and QPPV oversight to strengthen data quality from initial intake through regulatory submission. Billev Pharma East’s training programmes focus on improving report completeness and addressing the common root causes highlighted by the analysis. Clear role definition – including the pharmacovigilance manager function and clear interfaces with the pharmacovigilance vendor – also helps sustain report quality and consistent follow-up. This support can also include a pharmacovigilance risk management plan.

The study strengthens the evidence base underpinning these core services and demonstrates how Billev’s scientific depth translates into tangible client value.

This advanced training reflects the caliber of expertise Billev Pharma East brings to maintaining, evaluating, and continually improving pharmacovigilance systems for clients worldwide.

Why Expertise in Toxicology and Pharmacovigilance Matters

For Billev Pharma East, the study represents both an academic achievement and a demonstration of the company’s expertise in advancing drug safety. The findings will strengthen internal best practices and further enhance the value delivered to clients seeking dependable, science-led PV support across clinical, post-marketing, and outsourced environments.

The company commented:
“Jana’s study reaffirms why pharmacovigilance matters: it underpins drug safety, supports regulatory confidence, and ultimately protects patients. It also reflects the depth of toxicological and pharmacovigilance expertise that guides all our client engagements.”

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. Billev Pharma East supports clients in maintaining, evaluating, and improving pharmacovigilance systems worldwide.

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/

Resources

Click on  Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective to access Jana Brajdih Čendak article.
Click on Billev Pharma East Pharmacovigilance Services to learn more.