Black triangle products In the European Union (EU), medicines that are being monitored closely by regulatory authorities are labelled with a black inverted triangle (▼) in the product information. These medicines are described as being under ‘additional monitoring’. Medicines under additional monitoring carry a black triangle symbol (an inverted equilateral black triangle; ▼) to let patients and Health Care …
Introduction EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of human medicines. It constitutes experts in medicines safety from regulatory authorities in Member States, scientific experts and representatives of patients and healthcare professionals, which are nominated by the European Commission. EMA supports the PRAC by providing data from clinical practice available in electronic …
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Hello Freshers and Experienced PV professionals, I hope you all are doing well !! The most important question that Freshers have after their graduations/post-graduations is how to prepare for Pharmacovigilance (PV) Interviews in year 2022? and same is the case for experienced PV professionals regarding what exactly to read for PV interview. How to prepare …
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A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Mistakes in the prescribing, dispensing, storing, preparation and administration of a medicine are the most common preventable cause of undesired adverse events in medication practice and present a major public health …
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 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 …
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). …
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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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 …
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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