What is Pharmacovigilance Audit?
Patient safety and compliance with the regulations are the most important in the pharmaceutical industry. One of the key mechanisms to ensure that drug safety processes are effective, consistent, and compliant is the pharmacovigilance audit. This internal or external assessment assists with the evaluation of the strength of the pharmacovigilance system, identification of risk areas, and the proper monitoring of medicinal products during the lifecycle.
What is Package Inserts (PIs) ?
Package Inserts (PIs) are regulatory documents that are packaged with prescription medications, providing healthcare practitioners with crucial details of the safe and effective usage of the medications. PIs, approved by world health organizations, also include scientific information on indications, dosage, warnings, etc.
What Are Safety Labeling Changes (SLC)?
In the world of pharmaceuticals, drug safety doesn’t end at approval. Once a medication is on the market, its real-world use often uncovers new safety information that wasn’t visible during clinical trials. This is where Safety Labeling Changes (SLC) apply.
In a digital-first healthcare ecosystem, clarity, consistency, and easy access to information about drugs are more important than before. That’s where the Structured Product Monograph (SPM) comes in a modern, structured, and machine-readable version of a traditional product monograph.
Drug information is important in highly regulated world of pharmaceuticals because use of incorrect information may result in an injurious outcome. The Structured Product Labeling (SPL) is one of the basic instruments that the U.S. Food and Drug Administration (FDA) employs in this undertaking.
