What is ADRreports EU?
(ADRreports.eu portal). • This portal allows users to view the total number of individual suspected side effect reports (also known as Individual Case Safety Reports, or ICSRs) submitted to EudraVigilance for each centrally authorised medicine.
What is European database of adverse drug reactions?
European database of suspected adverse drug reaction reports (EudraVigilance) The dataset provides data on suspected side-effects also known as suspected adverse drug reactions for authorised medicines in the European Economic Area (EEA).
What is EEA in pharmacovigilance?
Monitoring suspected adverse reactions The Agency is responsible for developing and maintaining EudraVigilance, a system for managing and analysing information on suspected adverse reactions to medicines authorised in the European Economic Area (EEA).
What is adverse drug reporting?
Adverse drug reaction reporting helps the drug monitoring system to detect the unwanted effects of those drugs which are already in the market. To assess the knowledge, attitude, and practice of health care professionals working in Nekemte town towards adverse drug reaction reporting.
Who reports to EudraVigilance?
The European Medicines Agency
The European Medicines Agency is responsible for the development, maintenance and coordination of EudraVigilance, a system designed for the reporting of suspected side effects.
What is PSMF pharmacovigilance?
The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the MAH with respect to one or more authorised medicinal products. The PSMF is not part of the marketing authorisation (MA) dossier and is maintained independently from the MA.
What is Evctm?
The EudraVigilance Clinical Trial Module (EVCTM) to facilitate the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) as required by Directive 2001/20/EC.
What is rechallenge and Dechallenge in pharmacovigilance?
not conclusive indication of drug-induced disease. • In cases where a withdrawal reaction is experienced, a dechallenge is when. the drug is again given to the patient. • “Positive” dechallenge = improvement of reaction when dechallenge occurs. Rechallenge = reintroducing the drug after a dechallenge.
What is Argus database?
Oracle Argus is a comprehensive pharmacovigilance platform which enables pharmaceutical companies and clinical trial organizations to make faster and better safety decisions, optimize global compliance, and easily integrate risk management.
What are some examples of adverse events?
Adverse events include side effects to medicines and vaccines, and problems or incidents involving medical devices. Examples of adverse events are any unfavourable and unintended sign, symptom or disease associated with the use of a therapeutic good.
What are adverse medical events?
adverse event. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with that treatment.
What is a hospital adverse event?
An adverse event is an incident that results in harm to the patient. Adverse events commonly experienced in hospitals by patients over 70 include falls, medication errors, malnutrition, incontinence, and hospital-acquired pressure injuries and infections.
What is event reporting system in health care?
Patient safety event reporting systems are ubiquitous in hospitals and are a mainstay of efforts to detect patient safety events and quality problems. Incident reporting is frequently used as a general term for all voluntary patient safety event reporting systems, which rely on those involved in events to provide detailed information.