The 24-Hour Clock: Transforming the Drug Safety Mailbox with AI
In the world of Pharmacovigilance, the Drug Safety Mailbox is far more than an email address. It is the nerve center of patient safety—the first point of contact where patients, healthcare professionals, and partners report adverse events, product quality issues, and medical inquiries. Yet for many organizations, this critical mailbox has become a bottleneck. With […]
When a patient receives a prescription, they see only the tip of the iceberg—a simple medication meant to treat their condition. But beneath the surface lies a vast, complex infrastructure dedicated to keeping them safe. This powerful metaphor captures the essence of pharmacovigilance and the hidden layers of work that protect patients every day. The […]
The Audit Question That No One Wants to Answer In my years conducting audits, I often paused at the Business Continuity Plan (BCP) section and asked a simple, uncomfortable question: “If the internet stops working completely for 48 hours, how will you submit your expedited safety reports to the regulatory authorities?” The answers were often […]
Antimicrobial Resistance (AMR) is often called the “silent pandemic.” It is not just a future threat; it is happening now, affecting millions of lives globally. While we often think of AMR as a clinical or public health issue, there is a powerful, underutilized weapon in our arsenal: Pharmacovigilance. Based on the latest insights, here is […]
In the world of Pharmacovigilance, we often fixate on the technical: regulatory requirements, SOPs, and data integrity. While technical expertise is non-negotiable, it is only half the battle. To truly drive improvement and ensure patient safety, an auditor must master the human element. Soft skills are not just “nice to have”; they are essential competencies […]
In the world of Pharmacovigilance, identifying a risk is only half the battle. The true test of a safety system is its ability to manage that risk in the real world. As defined by the EMA GVP Module XVI, risk minimisation measures (RMMs) are interventions intended to prevent or reduce the occurrence of adverse reactions […]
The story of modern drug safety legislation begins with a sweet taste and a devastating consequence. The Sulfanilamide Disaster of 1937 stands as a grim monument to the catastrophic failure of drug regulation, yet decades later, the same toxic culprit—Diethylene Glycol (DEG)—continues to claim lives around the world. This recurrence raises a chilling question central […]
In the world of pharmacovigilance, few adverse events command as much respect and caution as Drug-Induced Liver Injury (DILI). It is a leading cause of acute liver failure in the Western world and remains the single most frequent safety-related reason for the withdrawal of drugs from the market. Whether you are in clinical development or […]
Aviation is a prime example of an industry where lives are at stake, and it shares striking similarities with pharmacovigilance—the science of monitoring and ensuring drug safety. Both operate in highly regulated, complex environments where human factors and automation play critical roles. Here are key lessons pharmacovigilance can learn from aviation’s extensive experience. 1. Safety […]
The other day someone asked me “What does it take to become a PV Auditor? Can I become one?”. I spontaneously responded that you should know the regulations, processes as well as some experience in the quality management system. Then came the tricky question, “How can I become a good PV Auditor?”. I knew this […]