Global Safety Database definition

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 11.2.

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.

Examples of Global Safety Database in a sentence

• At a mutually agreeable time during the R&D Pre-Transfer Period, the Parties will negotiate and execute in good faith an amendment to the Original Pharmacovigilance Agreement (as amended, the “Pharmacovigilance Agreement”) delineating the processes and procedures for sharing safety information with respect to the Product throughout the Territory (including the Additional Territory) and subsequently transferring responsibility for the Global Safety Database to Partner.

• Prior to the Execution Date, Xxxxx has established and maintained a Global Safety Database that contains and will contain all information and data arising from the Parties’ activities with respect to safety matters that is required to be contributed by each party pursuant to the Original Pharmacovigilance Agreement, including information and data arising out of any risk evaluation and mitigation strategy (REMS) and/or risk management plan (RMP), periodic safety reports and safety monitoring activities.

• During the R&D Post-Transfer Period, and notwithstanding anything to the contrary contained in the Original Pharmacovigilance Agreement, Partner shall be solely responsible for maintaining such Global Safety Database.

• Atara shall (i) continue to maintain such Global Safety Database during the R&D Pre-Transfer Period, and (ii) upon the end of the R&D Pre-Transfer Period, transfer such Global Safety Database to Partner.

More Definitions of Global Safety Database

Global Safety Database is defined in Section 5.2.

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 means the global safety database for the Licensed Compound.

Global Safety Database has the meaning set forth in Section 5.5(e).

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 means the database containing Serious Adverse Events, Serious Adverse Drug Reactions and pregnancy reports for the Combined Therapy, which database shall be the authoritative data source for regulatory reporting and responding to regulatory queries.

Global Safety Database means the database containing Serious Adverse Events, serious adverse drug reactions and pregnancy reports for the Product, and shall be the authoritative data source for regulatory reporting and responding to regulatory queries.