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According to World Health Organization( WHO), It is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
Pharmacovigilance, which is one of the unique careers, is associated with life science, medical and pharmacy. The role of this scientific discipline is to analyze the side effects of drugs; they monitor the safety of drugs that are available in the market.
Upon completing this Chapter you will be able to know about
Importance of Pharmacovigilance
What is the need and objective of Pharmacovigilance
Scope of Pharmacovigilance
Impact of the current system
ADRs and AEs
Features of PV Process: Who can report, Why to report, What to report, Where to report, How to report and different factors for reporting
This session will give you a good understanding of the basics of Pharmacovigilance and will play a key role to understand the key components used in the clinical and post-marketing settings of Pharmaco-vigilance and an overview of the process.
It is a document which describes the objectives, design, methodology, statistical considerations and management of a trial. It usually gives the background and rationale for the trial/Study as per format required by the Regulatory Authority.
ADRs AEs Reporting and Recording System
Individual Case Study Reports Case Processing and Case Assessment.
MedDRA stands for Medical Dictionary for Regulatory activities.
An aggregate report is a compilation of all newly available safety information produced during a defined reporting period
Causality is the relation between a cause(Drug) and its effect( Adverse drug reaction).