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Drug Safety Pharmacovigilance

Drug Safety and Pharmacovigilance

Join us for this free webinar on Career opportunities in Drug Safety and Pharmacovigilance.
Date: 7:30 PM EST, 30 Mar 2026

clinical research associate training

Clinical Data Management

Join us for this free webinar on Career opportunities in
Clinical Data Management.
Date: 7:30 PM EST, 23 Mar 2026

Clinical Research Training

Clinical Research

Join us for this free webinar on Career opportunities in
Clinical Research.
Date: 7:30  PM EST, 01 Apr 2026

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Latest Blog Articles

When Systems Fail: Lessons from an FDA Warning Letter

The U.S. Food and Drug Administration issued a Warning Letter to Novo Nordisk Inc. following an inspection conducted under the Bioresearch Monitoring Program. The inspection identified serious and systemic violations of postmarketing adverse drug experience (PADE) reporting requirements. Lessons learnt from this warning letter: 1. Inadequate Pharmacovigilance (PV) Procedures 2. Failure to Submit 15-Day Alert […]

Celebrating the Strength Behind Every Dream: Honoring Women on International Women’s Day – 08 March 2026

Every year on International Women’s Day, the world pauses to recognize the achievements, resilience, and contributions of women in every sphere of life. From boardrooms to classrooms, laboratories to homes, women continue to shape societies, economies, and families in ways that are both visible and often quietly profound. When we speak about women in the […]

Learn about E2B (R3) submissions for ICSRs.

This summary outlines the key points regarding the transition from the E2B(R2) to the E2B(R3) standard for Individual Case Safety Reports (ICSR) submissions. Overview of ICSR E2B R2 vs. R3 The E2B guideline, established by the International Council for Harmonization (ICH), provides the data elements and message specifications for the electronic transmission of ICSRs. While […]

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