Safety Data definition

Safety Data means Data related solely to any adverse drug experiences and serious adverse drug experience as such information is reportable to Regulatory Authorities. Safety Data also includes “adverse events”, “adverse drug reactions”, and “unexpected adverse drug reactions” as defined in the ICH Harmonised Tripartite Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.

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Safety Data means adverse event information and other information (if any) required by one or more Regulatory Authorities to be collected or to be reported to such Regulatory Authorities under applicable Laws.

Safety Data means Data related solely to any adverse drug experiences and serious adverse drug experience as such information is reportable to Regulatory Authorities. Safety Data also includes “adverse events”, “adverse drug reactions” and “unexpected adverse drug reactions” as defined in the ICH Harmonised Tripartite Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.

Examples of Safety Data in a sentence

Each Party shall be primarily responsible for reporting quality complaints, adverse events, and Safety Data related to the Licensed Products to any necessary Regulatory Authorities in its Applicable Territory, and responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products, [***].
Subject to compliance with Applicable Laws, each Party shall have the right to use the Safety Data resulting from Development activities performed by the other Party, without compensation to such other Party, in each case as reasonably necessary for the first Party to comply with its safety reporting obligations in its Applicable Territory.
Each Party agrees to comply with its respective obligations under the Safety Data Exchange Agreement and to cause its Affiliates, licensees, and sublicensees to comply with such obligations.
The Parties agree that the Safety Data Exchange Agreement shall apply to the pharmacovigilance and safety data exchange procedures in relation to the Trials, and the Parties shall perform their respective rights and obligations in accordance with the provisions set forth under the Agreement.
Licensor shall maintain, and [***] associated with maintaining, its own safety database for the Licensed Products in the Retained Territory and shall provide all Safety Data, including adverse event reports, in such database to Licensee in accordance with the Safety Data Exchange Agreement.

More Definitions of Safety Data

Safety Data means any Adverse Event information from Clinical Trials and all results from non-clinical safety studies, including toxicology and carcinogenicity data (if any), with respect to the Licensed Product required by one or more Regulatory Authorities to be collected or to be reported to such Regulatory Authorities under applicable Laws, but excluding any information related to the efficacy of the Licensed Product.

Safety Data means a defined set of facts or set of safety values collected from various aviation-related sources, which is used to maintain or improve safety;

Safety Data means adverse event or adverse experience information, as defined under 21 C.F.R. §600.80, or the equivalent under any other applicable law, and other information regarding health risks posed by a Product or the Active Ingredient, including Complaints and information from clinical studies.

Safety Data means any adverse event (as such term is used in the meaning set forth in Title 21 of the United States Code of Federal Regulations § 312.32 or its equivalents in the Territory) information from human trials and all results from non-clinical safety studies, including toxicology and safety pharmacology data, with respect to a Product required by one or more Regulatory Authorities to be collected or to be reported to such Regulatory Authorities under Applicable Laws, but excluding any information related to the efficacy of the Product.

Safety Data means pre-clinical and clinical data relating to the Product useful for or in connection with demonstrating the safety of the Product for use in humans. Each Party may use Safety Data of the other Party in connection with any regulatory filing, whether or not such filing is mandatory.

Safety Data means any and all data arising in Development, Commercialization or other use, testing or application of a Product which is related to the safety profile of such Product.

Safety Data means all Adverse Events, adverse drug reactions, complaints and similar reporting obligations required under applicable Law with respect to a pharmaceutical or biological product.