Adverse event processing & causality assessment is the preferred way to identify a drug product related risk and its association with patient safety. An Individual Case Safety Reports (ICSRs) is an important source of information that contains crucial data on an adverse event that a patient is experiencing when taking a drug. The purpose of […]
ICSR PROCESSING & PATIENT SAFETY Read More »
An important aspect of patient safety is Pharmacovigilance, that is the science and activities relating to the Detection, Assessment, Understanding, and Prevention of adverse effects or any other medicine-related problems. As an end-to-end pharmacovigilance service provider, DDReg is a key stakeholder in the drug safety spectrum and is committed to ensure utmost patient safety. Our
Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety Read More »
Florence Nightingale once said “The very first requirement in a hospital is that it should do the sick no harm” 1 This notion has been evolving ever since to provide utmost patient safety in the healthcare processes. Studies have emphasized that medication errors are one of the principal causes of adverse events in patients constituting
Medication errors: Self-medication Read More »
The pharmaceutical industry is one that is constantly growing and simultaneously facing challenges in Quality Management Maturity Program in US FDA. The onset of the pandemic has brought new obstacles that require immediate attention and innovative solutions. Quality assurance (QA) is a routine measure that ultimately ensures patient safety by making sure all pharmaceutical products
Quality Management Maturity Program by the CDER of the U.S. FDA Read More »
Drug safety is all about the right patient receiving the right drug at the right time for an improved outcome for each patient. To achieve this, a Qualified Person Responsible for Pharmacovigilance (QPPV) Training is held responsible for the pharmacovigilance services management of the quality of a pharmaceutical company. This could be a person who
Why QPPV Training is the Key to Pharmacovigilance Success? Read More »
