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What is Aggregate Reporting in Pharmacovigilance?
Aggregate Reporting in Pharmacovigilance involves compiling and analyzing safety data over time to identify trends and ensure regulatory compliance. Atvigilx provides reliable support for Aggregate Reporting in Pharmacovigilance.
How do you pronounce the word Pharmacovigilance?
farmakovigelens
What is a brief definition of the word 'pharmacovigilance'?
The definition of the word pharmacovigilance is the assessment of the safety of drugs. This can be in the development pipeline, or in the post-marketing phase.
What are the three major components of pharmacovigilance?
The three major components of pharmacovigilance are adverse event reporting, signal detection and evaluation, and risk management. These elements work together to ensure the continuous monitoring of a medicine’s safety throughout its lifecycle, forming a core part of comprehensive pharmacovigilance services. Atvigilx provides these pharmacovigilance services across India, the USA, and Europe, supporting global compliance, efficient safety monitoring, and high-quality regulatory submissions.
What is ICSR case processing in pharmacovigilance?
ICSR case processing in pharmacovigilance involves collecting, validating, and evaluating adverse event reports to protect patient safety. Atvigilx delivers this service with accuracy and speed.
What is the medical term meaning study of the adverse effects of drugs on living organisms?
This is known as pharmacovigilance.
What kind of jobs can one get in the area of pharmacovigilance?
The word Pharmacovigilance can be abbreviated as PhV and is also known as drug safety. The jobs available in this career path range from scientists investigating the safety of drugs to simply being a test subject when it proceeds to human trials.
What does the medical abbreviation PV mean?
PV can mean per vaginum (indicating a medication such as yeast treatment cream to be inserted vaginally) or pharmacovigilance, depending on the context.
What is pharmacovigilance in clinical research?
Pharmacovigilance, also known as drug safety, is the science of understanding the adverse effects caused by a drug and assessing whether the benefit will outweigh the peril. This includes detection of adverse effects during the clinical trials and post marketed phases, monitoring and updating the risk-benefit ratio determined upon relevant findings, prevention or minimization of adverse effects, and most crucially, harmonized communication of those findings to the affected global regulatory authorities during a timely manner.
What is a p-value in pharmacovigilance?
A p-value in pharmacovigilance is a statistical measure that helps determine the strength of evidence against a null hypothesis, often related to the safety and efficacy of a drug. It quantifies the probability of observing the data, or something more extreme, assuming that the null hypothesis is true. A low p-value (typically ≤ 0.05) suggests that the observed effect is unlikely to be due to chance, indicating a potential association between the drug and adverse events. This aids regulatory bodies in assessing the risk-benefit profile of pharmaceuticals.
What is the medical term meaning study of adverse reactions or drug interactions?
The medical term for the study of adverse reactions or drug interactions is pharmacovigilance. It involves monitoring the safety of medications and assessing their risks and benefits in real-world settings.
What is periodic reporting in pharmacovigilance?
Periodic reporting in pharmacovigilance involves compiling and evaluating a medicinal product’s safety data at regular intervals to assess emerging risks, identify trends, and ensure that its benefit–risk profile remains favorable. The key document used for this purpose is the Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER), which includes ICSRs, clinical findings, literature data, cumulative trends, and safety signals in a structured, guideline-compliant format. This process ensures continuous monitoring, regulatory compliance, and enhanced patient safety throughout the product’s lifecycle. In the second stage of this work, organizations rely on specialized partners for accuracy and compliance. Atvigilx supports companies by preparing, reviewing, and managing periodic safety update reports in pharmacovigilance, ensuring scientific precision, timely submissions, and fully compliant safety documentation.
