Table of Contents
What is included in pharmacovigilance?
Pharmacovigilance (PhV) is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem [549].
What are pharmacovigilance methods?
Background: Pharmacovigilance, defined by the World Health Organisation as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’ plays a key role in ensuring that patients receive safe drugs.
Why is the need of pharmacovigilance?
The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. In other words, analysing which side effects are worth the risk to patients compared with how effective they are at treating a disease.
What is pharmacovigilance surveillance?
Pharmacovigilance: An Active Surveillance System to Proactively Identify Risks for Adverse Events.
Why is pharmacovigilance needed?
What is the process of Pharmacovigilance?
Pharmacovigilance process Detection: Collection of Individual Case Safety Reports (ICSRs) Assessment Understanding and Prevention of adverse effects
What does a drug safety associate (DSA) do?
Drug safety associates often monitor drug trials for safety and to ensure they are following proper procedure. Aside from conducting investigations, the drug safety associate is also responsible for designing, implementing and maintaining the drug safety management programs.
What is pharmacovigilance system master file?
The pharmacovigilance system master file is actually a detailed description of the pharmacovigilance and safety procedures which a company follows when handling a product. It is a very useful document for the regulators and the MAH which ensures that noncompliance issues or deficiencies in the pharmacovigilance system will get detected.
What is a drug safety associate?
Drug safety associates are responsible for performing a wide variety of tasks related to drug safety. They are in charge of reviewing and evaluating adverse events related to use of pharmaceutical drugs, serving as a point of contact for stakeholders on safety activities, and identifying safety signals.