Sage-Tips

What database are used in pharmacovigilance?

VigiBase
VigiBase, the international pharmacovigilance database, is now aggregating over 21 million individual case safety reports in 2020.

What is Arisg database?

LifeSphere MultiVigilance (formerly ARISg/ARISc) – A Pharmacovigilance Database for Chinese Regulatory Compliance.

What is a drug safety database?

Drug safety databases contain professional assessment of the potential of drugs. This database permits the risk- profit analysis of medicinal products taking under consideration new and emerging information, within the context of additive data.

What is Argus software pharmacovigilance?

Oracle Argus Safety is a comprehensive platform designed specifically to address the life science industry’s complex pharmacovigilance requirements. Argus Safety’s advanced database helps ensure global regulatory compliance, enables sound safety decisions and integrates safety and risk management functions.

What is GVP module?

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.

What is nullification in PV?

Case Nullification- When case is found to be duplicate of pre-existing case but submissions of reports was done in previous version. In such scenario, the duplicate case cannot be deleted directly but needs nullification.

What is the best drug safety database / pharmacovigilance database?

Clinevo safety is the best drug safety database /Pharmacovigilance Database which works towards reduction of end user efforts through constant automation and AI capability enhancements.

What is pharmacovigilance software?

December 20, 2017 Pharmacovigilance (PV) software (also Safety databases) comprises drug safety management software solution that enables to create, classify, review, submit, and maintain pharmacovigilance data and adverse event reports (also known as ICSRs).

What is all-in-one pharmacovigilance?

All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety Signals capabilities under one platform. Clinevo Pharmacovigilance software / drug safety software Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

How can pharmacovigilance databases be used for retrospective observational studies?

Integrating signal detection, pharmacovigilance databases can be used for a wide variety of retrospective observational studies illustrated here by concrete examples. Confirming these signals by orthogonal validation using pre-clinical platforms and prospective trials is helpful.