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 the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible health product 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.
Examples of pharmacovigilance in a sentence
The Parties agree to enter into a Pharmacovigilance agreement in accordance with this Section 7.3 within a reasonable time of Launch.
All Pharmacovigilance with respect to the Product shall be the sole responsibility of THI who shall promptly provide Cumberland with any information of which it becomes aware concerning the safety or efficacy of the Product.
More Definitions of pharmacovigilance
pharmacovigilance means the process of monitoring and investigating adverse events;
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 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 the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other therapeutic good related problems.
pharmacovigilance means the practice of monitoring the effects of medical
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 science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems. The decision to approve a drug is based on a satisfactory balance of benefits and risks within the conditions specified in the product labeling. This decision is based on the information available at the time of approval. The knowledge related to the safety profile of the product can change over time through expanded use in terms of patient populations and the number of patients exposed. In particular, during the early post-marketing period the product might be used in settings different from clinical trials and a much larger population might be exposed in a relatively short timeframe. Detailed evaluation of the information generated through pharmacovigilance activities is important for all products to ensure their safe use.