GVP

GVP is the practice of monitoring the effects of medical drugs after they have been licensed for use, especially to identify and evaluate previously unreported adverse reactions.

Pharmacovigilance is required through the entire life cycle of a drug – starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market.

Pharmacovigilance includes collecting, analyzing, and monitoring adverse events reports, to work on the prevention of adverse effects in new drugs and therapies.

The audit will review the surveillance, operation, and systems. When auditing surveillance, one will review the analysis of the drug safety information. Ensure there are development safety update reports (DSURs) for drugs in clinical research and periodic benefit-risk evaluation reports (PBRER) for drugs that are on the market.

Auditing for operations will focus on the collecting and recording of information during preclinical development, and early clinical trials.

Also, to review the gathering of real-world evidence (RWE) of adverse events reported by medical professionals and patients.

Auditing of the systems will be concerned with the reviewing of the systems in place to store and manage data relating to pharmacovigilance. The system should keep abreast of changing regulations and guidance in the pharmacovigilance industry and ensure compliance at all levels of an organization.