Pharmacovigilance Glossary Terms

GLOBAL SAFETY DATABASE: Means a database where it is collected all the Adverse Events, Serious Adverse Events, Serious Adverse Drug Reactions, and pregnancy report occurred during a clinical Trials or in case of Authorised Medicinal Product, all the adverse events reported directly by a health care professionals or users to the Marketing Authorisation Holder or Competent Authority website (special tab for this purpose).