Principles and Regulations in Pharmacovigilance

Pharmacovigilance involves the collection of data on Adverse Reactions which must then be analysed and evaluated to create meaningful safety information. The process of signalling involves looking at the adverse reaction data for patterns that suggest new safety information. This content provides a brief introduction to the definition and purpose of signals and some of the key methodologies employed to generate them by validation. Healthcare professionals are encouraged to report adverse reactions via national spontaneous reporting systems. Consumers and patients may also report adverse reactions in this way as well as via a wide variety of media, including the internet. Relevant information may also be made available from other soures, such as poisons centres. All steps taken and recommendations made must be accurately tracked and documented at every stage to assure quality control. There are resulting legal obligations which must be fulfilled in an accurate and timely manner but the ultimate goal is to confirm or refute whether there is some new issue with the safety of a medicine so that action might then be taken to reduce the risk by following good manufacturing practices.

Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority. 

  • Controlled Good Manufacturing Practices
  • Control of Production Procedures
  • Control of Finished Products
  • Types and Protocols of Validation
  • Quality Assurance and Quality Control
  • Statistical Quality Control

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