Pharmacovigilance, also known as drug safety, is a broad term that describes the collection, analysis, monitoring, and prevention of the various side effects of the drugs and treatments. This is completely a scientific and process-oriented pharmaceutical field.
It is perhaps the most important function of a life sciences company. Companies must follow strict rules to develop, manufacture, and commercialize pharmaceuticals. Most of these regulations focus on patient safety and the added benefit of the drug to the patient. In short, this is the task of drug safety and highlights why this field plays such a central and important role in the area of medicine. Clinical research courses and Training is required to be a professional in this field.
Why is it important?
Safety and Well- being of Patients:
Drug safety ensures the safety and well-being of patients throughout the drug development life-cycle, including when the drug is already in the market. In fact, the drug is constantly monitored for any other side- effects in patients, and all new data is collected and reported regularly to the health authorities. While other disciplines too; focus on improving patients’ lives in everything they do.
Maintain Safety Records:
Pharmacovigilance services in India are provided by qualified and experienced clinical research professionals. It not only helps to maintain a safety record of all minor and major security incidents, but also helps prevent these security breaches with thorough reports.
A Case Safety Report (CSR) is a report that addresses the difficulty experienced by each person participating in the trial as a participant. Once the relevant data is used for existing projects, these reports are archived for other future projects.
Project-specific Safety Approach:
Reporting safety-related adverse events (SAE) is an important step in a drug development process. Authorities examine SAE reports and other drug development documents. The service provider assists the project sponsor by collecting all the necessary documents that must be sent to the authorities for drug evaluation. And finally, the evaluation process leads to approval or rejection of the drug, which determines whether the drug will be produced for the public or sent back to a laboratory for further studies.
Steps in Pharmacovigilance Program:
- Safety data management
- Signal detection for any new altered safety issue
- Signal evaluation and making decisions with regard to safety issues
- Actions, including regulatory, to protect public health
- Spontaneous reporting
As the core mission of life sciences has always been to improve and save the lives of patients around the world, pharmacovigilance will continue to play an important and influential role in the development of future new drugs and therapies. It is important for drug regulatory authorities to make appropriate decisions to protect public health.
Therefore, this should be seen as a very important obligation, rather than an additional clinical burden, for healthcare professionals to ensure safer drug use worldwide.
