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
Direct access to the Global Safety Database will not be granted to Kaken, but Kaken will have the right to access, and Astria will provide, necessary safety information for the Licensed Products from and to the Global Safety Database in response to any reasonable safety information request from Kaken in accordance with the terms of the Pharmacovigilance Agreement.
More Definitions of Global Safety Database
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 means the database containing worldwide safety data including Adverse Events, Serious Adverse Events, adverse reactions, Serious Adverse Drug Reactions, safety reports related to special situations for the Product as defined in the applicable Laws, and pregnancy reports for the Product.
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 defined in Section 5.2.
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.