Pharmacovigilance definition

Pharmacovigilance means the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug- related problem;

Pharmacovigilance means all the activities associated with maintaining an effective drug safety monitoring system and adverse events reporting system in compliance with the requirements of Regulatory Authorities.

Pharmacovigilance means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible health product related problem;

Examples of Pharmacovigilance in a sentence

• Pharmacovigilance and safety, regulatory support, quality control and clinical support are provided to the Company through the GVI CDS agreement.

• The Pharmacovigilance system described fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the identification and notification of any potential risks occurring either in the Community or in a third country.

• The Division of Pharmacovigilance (DPV) conducted this review in accordance with the Food and Drug Administration Amendments Act (FDAAA) Pediatric Research Equity Act (PREA).

• Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations.

• The Pharmacovigilance system described fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the identification and notification of any a potential risks occurring either in the Community or in a third country.

More Definitions of Pharmacovigilance

Pharmacovigilance means the process of monitoring and investigating adverse events;

Pharmacovigilance means the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions, and includes the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem;

Pharmacovigilance means activities comprising detection, assessment, understanding and prevention of adverse reactions and acting in the event of their occurrence as well as new knowledge about any unsafe administration of medicinal products,

Pharmacovigilance means the practice of monitoring the effects of medical

Pharmacovigilance means the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problem, or any updated definition published by the World Health Organization from time to time.

Pharmacovigilance means science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. In line with this general definition, underlying objectives of Pharmacovigilance in accordance with the applicable EU legislation for are: 1) preventing harm from adverse reactions in humans arising f rom the use of authorised medicinal products within or outside the terms of marketing authorisation or f rom occupational exposure; and 2) promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public. Pharmacovigilance is therefore an activity contributing to the protection of patients and to public health.

Pharmacovigilance means the process of monitoring the risk/benefit balance of an authorized medicinal product, including the collection, recording and management of Safety Data, in order to examine whether there is any new or changing safety hazard that requires action to be taken to protect patients, and including, where appropriate, communication with the Regulatory Authority to agree on an appropriate risk management strategy.