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 experiences as such information is reportable to Regulatory Authorities in the Licensed Territory or Retained Territory. 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

• To the extent that the goods to be supplied by the Contractor contain or may create hazardous substances, harmful physical agents or infectious agents as set forth in applicable state and federal laws and regulations, the Contractor must provide Material Safety Data Sheets regarding those substances.

• To the extent applicable to the Work and they exist, Customer shall provide Company with any reports or Material Safety Data Sheets required by OSHA.

• If, pursuant to 29 CFR 1910,1200, a Material Safety Data Sheet is required to be provided with the goods ordered hereunder, the Order shall not be considered complete by Buyer, and payment may be withheld, until such time as the Material Safety Data Sheet is received.

• Each chemical substance contained in Goods is on the inventory of chemical substances compiled and published by the U.S. Environmental Protection Agency pursuant to the Toxic Substances Control Act; and all required Material Safety Data Sheets, Chemical Safety Data Sheet and other product-content information shall be provided to AGILENT prior to or with the shipment of the Goods and shall be complete and accurate.

• Seller warrants that all Materials Safety Data Sheets required to be provided by Seller for Goods shall be provided to Agilent prior to or together with shipment of the goods and shall be complete and accurate.

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 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 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 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 Data generated by or on behalf of LGC or its Affiliates or Sublicensees or by or on behalf of Cue or its Affiliates or Cue Collaborators, related solely to any adverse drug experiences and serious adverse drug experiences as such information is reportable to Regulatory Authorities in the applicable Party’s Territory. 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 a defined set of facts or set of safety values collected from various aviation-related sources, which is used to maintain or improve safety ;