Pharmacovigilance Archives - Page 6 of 6

Preparedness for inspections: Are you prepared for the upcoming pharmacovigilance inspection?

Regulatory authorities around the world conduct pharmacovigilance (PV) inspections to verify that marketing authorization holders (MAHs) and allied organizations maintain compliance with PV requirements, obligations, and relevant standards. This applies to products as well as processes. National competent authorities appoint inspectors to conduct these inspections which can be announced or unannounced. If the former, then […]

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Automation in Pharmacovigilance and Drug Safety

Blogs, Pharmacovigilance / development

The integration of artificial intelligence (AI) and machine learning (ML) technology into the pharmaceutical and life sciences industry is demonstrating significant benefits on several fronts. Whether it is incorporation of real-world data into clinical investigations or automation of operations to streamline key processes, technology is driving the industry forward. Pharmacovigilance is part of the industry

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Steps of ICSR PROCESSING in PATIENT SAFETY

ICSR PROCESSING & PATIENT SAFETY

Blogs, Pharmacovigilance / development

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

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Pharmacovigilance Services in DDregpharma

Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety

Blogs, Pharmacovigilance / development

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

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Medication errors: Self-medication

Blogs, Pharmacovigilance / development

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

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Quality Management Maturity Program by the CDER of the U.S. FDA

Blogs, Pharmacovigilance / development

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

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Why QPPV Training is the Key to Pharmacovigilance Success?

Blogs, Pharmacovigilance / development

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

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