Risultati per 'pharmacovigilance':
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farmacovigilanza - agenzia italiana del farmaco
Farmacovigilanza. La farmacovigilanza è l’insieme delle attività che contribuiscono alla tutela della salute pubblica. Esse infatti sono finalizzate all'identificazione, valutazione, comprensione e prevenzione degli effetti avversi o di qualsiasi altro problema correlato all'uso dei medicinali, per assicurare un rapporto beneficio/rischio ...
pharmacovigilance: overview - european medicines agency (ema)Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.
pharmacovigilance - wikipediaPharmacovigilance. Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare ...
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good pharmacovigilance practices - european medicines agency (ema)Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.
pharmacovigilance - european commission - public healthPharmacovigilance activities. Collecting and managing data on the safety of medicines. Looking at the data to detect "signals" (any new or changing safety issue) Evaluating the data and making decisions with regard to safety issues. Pro-active risk management to minimise any potential associated risks. Acting to protect public health (including ...
regulation and prequalification - world health organization (who)Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
legal framework: pharmacovigilance - european medicines agency (ema)The pharmacovigilance legislation, which came into effect in July 2012, was the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It had significant implications for applicants and holders of EU marketing authorisations, as well as for patients, healthcare professionals and regulators.