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.
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
The JSC shall establish a safety subcommittee, and all Safety Data, including adverse event reports, shall be submitted to such safety subcommittee and Immutep promptly so that Immutep may update the global safety database accordingly.
Such safety subcommittee shall coordinate with respect to any Safety Data reporting for the Product to the Regulatory Authorities in the ▇▇.
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 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 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 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.