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 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 has the meaning set forth in Section 8.2.

Examples of Global Safety Database in a sentence

• Information provided as part of an adverse event report is shared within Biogen on a worldwide basis through Biogen’s Global Safety Database, hosted in the United States by Biogen, Inc.

• The Pharmacovigilance Agreement shall, among other things, govern cooperation between the Parties that will enable each of them to comply with its respective obligations under applicable Laws with regard to adverse event data collection, analysis and reporting and to enable each Party to satisfy its duty of care, and to govern the Global Safety Database.

• These signal detection activities shall include, but are not limited to, proactive review and evaluation of all safety information from the Global Safety Database (including by way of example, Individual Case Safety Reports, aggregate safety information, literature reports, and non-clinical data).

• The Principal shall maintain the Global Safety Database in accordance with (and as defined in) the Pharmacovigilance Agreement.

• NORGINE will be responsible for the management and processing in the Global Safety Database of ICSRs identified in worldwide published literature and local literature.

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, 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.

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;