Month: November 2021

Automation and Artificial Intelligence (AI) in Pharmacovigilance

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Hello Guys, Nowadays, Automation and Artificial Intelligence (AI) in Pharmacovigilance is a “Buzz” word in Pharmacovigilance industry. Automation empowers organizations to recognize greater efficiency, quality of work and the speed at which manual tasks can be accomplished while re-directing valuable resources to focus on higher-order tasks.  Automation helps in addressing the global requirements of detection, assessment …

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Labelling in Pharmacovigilance

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Labelling is an Information on the immediate or outer packaging. For a product with an approved marketing application, any reaction which is not mentioned in the official product information is unlabeled. If it is included, it is termed labeled.  Labelling in Pharmacovigilance Reference safety information In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information …

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Basic facts about EudraVigilance and EVDAS

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Hello PV Aspirants and PV Professionals, In this article we will understand some basic facts about EudraVigilance and EVDAS (EudraVigilance Data Analysis System). EudraVigilance EudraVigilance database EudraVigilance is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). …

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Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEA)

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Hi All, Let’s understand about Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEA). Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEA) Pharmacovigilance Agreements (PVAs) A pharmacovigilance agreement (PVA) is a written agreement between the marketing authorisation holder (MAH) and a third party (to which the MAH has shared or activities regarding or impacting pharmacovigilance), which outlines the responsibilities …

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Understand Basics of MedDRA in 5 minutes

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Hello Guys, In this article we will see some basics of MedDRA (Medical Dictionary for Regulatory Activities). MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. MedDRA is published by the International Council for Harmonisation, used in particular for coding cases of adverse effects in clinical study reports and pharmacovigilance …

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Understanding PSMF and Role of QPPV in Pharmacovigilance

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Hello Guys, In this article, we will see about Pharmacovigilance System Master File (PSMF) and role of Qualified Person responsible for Pharmacovigilance (QPPV).   PSMF is a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products. The PSMF shall be located either at the …

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