Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness.

Background: Pharmacovigilance (PV) inspections are critical regulatory assessments that evaluate the robustness and compliance of a company's drug safety system. Despite their significance, there is limited published guidance on how organizations-particularly Medical Safety functions-can prepare operationally for such inspections.

Objectives: To share practical, experience-based insights and organizational strategies for inspection readiness, execution, and follow-up, based on a recent large-scale European Medicines Agency PV inspection.

Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry.

The Short Bowel Syndrome (SBS) Registry (NCT01990040) is a multinational real-world study evaluating the long-term safety of teduglutide in patients with SBS and intestinal failure (SBS-IF) in routine clinical practice. This paper describes the study methodology and baseline characteristics of adult patients who have (ever-treated) or have never (never-treated) received teduglutide. A total of 1411 adult patients (679 ever-treated; 732 never-treated) were enrolled at 124 sites across 17 countries.