What is Orphan Drug Designation (ODD)? Orphan Drug Designation (ODD) is a regulatory designation that applies to those types of medicine which have been specifically designed to treat a rare disease commonly referred to as an orphan disease. These diseases affect a small fraction of the population, and because of the limited market potential, pharmaceutical… Continue reading What is Orphan Drug Designation (ODD)
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What is Pharmacovigilance System Setup
What is Pharmacovigilance System Setup? Pharmacovigilance (PV) is an important part of the pharmaceutical sector as it plays a crucial role in ensuring safety of medicinal products in their lifecycle. Marketing Authorization Holder (MAH) and clinical research organizations (CROs) are obliged to establish a compliant pharmacovigilance system in accordance with the requirements of global regulations.
What is Pharmacovigilance Audit
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,… Continue reading What is Pharmacovigilance Audit
What is Package Inserts (PIs)
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)
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.
What is Structured Product Monograph (SPM)
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.
What Is Structured Product Labeling (SPL)
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.
What is Patient Information Leaflet (PIL)?
What is Patient Information Leaflet (PIL)? Understanding your medication is as important as taking it correctly. One of the key tools that help patients make informed decisions about their health is the Patient Information Leaflet (PIL). Chances are, whether you are prescribed medication or purchase an over-the-counter product, it will have a PIL.
What is Submission eValidation
Accuracy and compliance are the key in the pharmaceutical profession and particularly when they present regulatory materials to health authorities. The simplest formatting mistake might mean rejection or subject to expensive delays. Submission eValidation guarantees that your electronic submissions are completed in all technical and structural compliance prior to sending regulators.
What is Submission Level Publishing
What is Submission Level Publishing? Regulatory submissions in the pharmaceutical industry are key processes that will dictate whether a drug or a medical product will make it to the market. In the setting of highly demanding regulatory requirements and complicated documentation, there has been the development of submission level publishing as a very important process… Continue reading What is Submission Level Publishing