What is pharmacovigilance?
The word “pharmacovigilance” derives from the Greek word pharmakon which means “medicine”, and the Latin word vigilare which means “ to keep watching”).
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
Due to increasingly stringent regulatory requirements, Pharmacovigilance landscape is continually evolving and has become an important and integral part of clinical research and drug development.
Pharmacovigilance consists in:
- Collecting and analysing safety information during drug development
- Monitoring the use of medicinal products in everyday clinical practice, so as to be able to identify previously unidentified adverse reactions or a change in the nature of adverse reactions.
- Perform risk-benefit assessments of medicinal products, in order to to decide what action to taken, if necessary.
- Provision of information to healthcare professionals as well as to patients in order to improve the safe and effective use of medicinal products.
Both clinical trials safety and post marketing Pharmacovigilance are critical throughout the product life cycle. Thus, the need for robust pharmacovigilance systems remains of paramount importance.