Global Safety Database definition
Global Safety Database means the database containing serious adverse events, serious adverse drug reactions and pregnancy reports for the Combined Therapy, and shall be the authoritative data source for regulatory reporting and responding to regulatory queries.
Global Safety Database means the database containing Adverse Events, Serious Adverse Events, Serious Adverse Drug Reactions and pregnancy reports for the Combined Therapy, and shall be the authoritative data source for regulatory reporting and responding to regulatory queries with respect to the Combined Therapy Clinical Trial.
Global Safety Database has the meaning set forth in Section 8.2.
Examples of Global Safety Database in a sentence
The ICT Group shall maintain a safety database for the Product for the ICT Territory, and will provide an initial transfer of safety information from its safety database to the Global Safety Database and thereafter provide safety reports to Lyell in accordance with the Pharmacovigilance Agreement.
More Definitions of Global Safety Database
Global Safety Database means, with respect to each medicinal Product, the database that is the central global repository for all individual case safety reports and other reports of Adverse Events with respect to such Product.
Global Safety Database is the database containing all ICSRs for all marketed medicinal products and all SAE reports (for Investigational Medicinal Products) that will be used by the Party responsible for the Global Database for safety monitoring activities, regulatory reporting and responses to safety queries from Regulatory Authorities for the Product.
Global Safety Database has the meaning set forth in Section 5.5(e).
Global Safety Database is defined in Section 5.2.
Global Safety Database means the global safety database for the Licensed Compound.
Global Safety Database or “GSD” means the safety database system used to capture, process, and report ICSRs. For purposes of this Agreement, the GSD is the database containing safety information for ATR Compounds and DNA-PK Compounds and is the authoritative data source for Individual Case Safety Report (ICSR) reporting and analysis.
Global Safety Database. ("GSD") shall mean the database containing all Adverse Events and pregnancy reports for the Product that will be used for regulatory reporting and responses to safety queries from Regulatory Authorities. Adverse Event (AE) shall have the official meanings or definitions as provided by and as further defined or modified by the applicable law and Regulatory Authorities;