E2B (R3) fields relevant for detection of signals and unapproved use patterns with end view of EudraVigilance access

PrimeVigilance is pleased to present a webinar featuring Dr. Cvijeta Bielen, Medical Director, on “E2B (R3) Fields for Signal Detection and Unapproved Use Patterns within EudraVigilance Access.”

This session provides an in-depth look at how E2B (R3) fields and access to EudraVigilance (EV) data can enhance signal detection capabilities and identify unapproved use patterns. Dr. Bielen will outline the critical E2B fields used in signal detection, such as those that clarify temporal relationships, confounding factors, and risk and mitigating factors, and discuss how MAHs can utilize EV data to support regulatory requirements for product labeling and safety monitoring.

In addition to optimizing signal detection processes, this webinar addresses the use of EV data and E2B fields—like reaction/event and sender’s diagnosis fields—to analyze unapproved use patterns, providing valuable insights into compliance and proactive monitoring. Dr. Bielen will also explore the MedDRA terminology, relevant E2B fields, and new validation rules within safety databases to enhance the monitoring of unapproved product use for EEA products, referencing the XEVMPD.

Key Takeaways Include:

• Overview of E2B (R3) fields critical to effective signal detection and analysis in pharmacovigilance
• Practical guidance on using EV data for identifying unapproved use patterns and supporting regulatory compliance
• Insights into the regulatory perspective for product label maintenance through continuous signal detection
• Exploration of MedDRA terminology, E2B fields, and validation rules to monitor unapproved use effectively