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Volume 10 - Clinical trials. Concerning Veterinary Medicinal Products: Volume 5 - Pharmaceutical Legislation. Volume 6 - Notice to Applicants. Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous:
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 (Latin for to keep ...
(Volume 1 is a tabular listing, and volume 2 is an index.) Extended for ICD-9-CM; Volume 3 contains procedure codes for surgical, diagnostic, and therapeutic procedures. [17] ICD-9-CM only; The NCHS and the Centers for Medicare and Medicaid Services are the US governmental agencies responsible for overseeing all changes and modifications to the ...
The Common Terminology Criteria for Adverse Events (CTCAE), [1] formerly called the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse events of drugs and treatment used in cancer therapy.
In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No ...
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
In the fortunate situation that the experimental arm is shown to be undeniably superior to the control arm, the DMC may recommend termination of the trial.
Since 1978, responsibility for managing the WHO Programme for International Drug Monitoring has been carried by UMC. [2] In the early years the staff consisted of just three pharmacists, Sten Olsson, Cecilia Biriell and Marie Lindquist, based at the Swedish Medical Products Agency (Läkemedelsverket); [3] Currently over 150 staff work in central Uppsala.