Core Data Sheet definition

Core Data Sheet means a document setting forth material relating to safety, indications, dosing, pharmacology, and other information concerning a product, as such document is described in ICH guidance E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, November 1996 (published by the FDA in May 1997), as amended from time to time.
Core Data Sheet means a document setting forth information relating to safety, efficacy, indications, dosing, pharmacology, and other information concerning the Product.
Core Data Sheet means the internal Amgen-developed document that sets forth the efficacy and safety profile for a Product.

Examples of Core Data Sheet in a sentence

  • Novartis shall be responsible for the core safety information to be included in the Investigators’ Brochure and Core Data Sheet.

  • The Company Core Data Sheet (CCDS) is not accepted as RSI by itself.

  • Information about common side effects already known about the investigational drug can be found in the Investigator Brochure (IB) or Core Data Sheet (for marketed drugs) or will be communicated between IB updates in the form of Investigator Notifications.

  • Overall conclusion Based on the data available from post-marketing experience, it is AstraZeneca’s opinion that the information in the current document and the AstraZeneca Core Data Sheet continues to accurately reflect the known benefit-risks for COVID-19 Vaccine AstraZeneca.

  • The required submission will simply be the Core Data Sheet, attached with this document.

  • The Local PPIs, along with the National PPIs included within the Core Data Sheet, form a tool for the improvement of property and property service performance.

  • The Council has worked hard to ensure that the indicators, shown in the Core Data Sheet and in Appendix E, have been informed by the best available data from a myriad of sources from across the Council departments.

  • It includes the performance outcomes in relation to the National PPIs, which are attached to the Core Data Sheet, as well as locally developed indicators (including the stakeholder surveys referred to in paragraph 3.2 above), which is attached as Appendix E.

  • The amount of fuel (litres) on the record sheet reduced whenever fuel was drawn for use in the Mission vehicles and a register established.

  • However, in order to mitigate the risk and in line with the FDA US class labeling request, the MAH decided to update its Core Data Sheet (CDS) for ibandronic acid oral formulations in the osteoporosis as well as oncology setting.


More Definitions of Core Data Sheet

Core Data Sheet means, for a given pharmaceutical product, an internal document that is owned by the marketing authorization holder of such product and that presents such marketing authorization holder’s position on the safety profile of such product.
Core Data Sheet means a document setting forth material information relating to safety, efficacy, indications, dosing, pharmacology and other information concerning the Licensed Product that will serve as a global reference document and basis for local labeling for use in Regulatory Filings or in discussions with Regulatory Authorities in the Territory.
Core Data Sheet means a document setting forth material information relating to safety, efficacy, indications, dosing, pharmacology and other information concerning the Product that will serve as a global reference document and, subject to Section 8.1.6(a), the basis for local labeling for use in regulatory filings and discussions with Regulatory Authorities in the Territory. 1.31 “Corporate Names” means (a) in the case of SGI, the trademarks “Seagen” and “Seattle Genetics” and the SGI corporate logo or such other names and logos as SGI may designate in writing from time to time and (b) in the case of Genmab, the trademark “Genmab” and the Genmab corporate logos or such other names and logos as Genmab may designate in writing from time to time, in each case ((a) and (b)), together with any variations and derivatives thereof. 1.32 “CSO” means a contract sales force organization. 1.33 “CVO Activities” means, with respect to the Product: (a) meetings with or presentations to (in-person or otherwise) physicians, administrators, or other professionals identified in an applicable Medical Affairs Plan that are conducted in a hospital setting or with Payors, in each case, with respect to clinical value and outcomes (CVO), and (b) clinical value and outcomes activities conducted with any hospital, health system, Payor, or any other Person. 1.34 “Detail” means a face-to-face meeting (including a virtual face-to-face meeting or group presentation, if in accordance with an applicable Approved Plan or otherwise approved by the JCC), including any such meeting conducted in a hospital or physician’s office (a) with one or more physicians and other persons included in other medical professional categories identified in the applicable Commercialization Plan (such individuals, “Target Prescribers”) (where, in the case of group presentations, each such physician or other person participating in a group presentation shall be counted as a separate Detail), in each case, who are permitted under the Applicable Law of the country in which they work to prescribe the applicable Product, in which such meeting key Product attributes are orally presented consistent with the terms of this Agreement. As of the Effective Date and so long as the Product has obtained Regulatory Approval for only one Disease in the United States (or other country or region in a Major Market), “Details” for purposes of this Agreement include only Primary Position Details; provided, that in connection with the Launch of the ...
Core Data Sheet means a document setting forth material relating to safety, indications, dosing, pharmacology, and other information concerning a product, as such document is described in ICH guidance E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, November 1996 (published by the FDA in May 1997), as amended from time to time. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Core Data Sheet means a document prepared by the Regulatory Approval holder containing, in addition to the Company Core Safety Information (CCSI), material relating to the CC Indication, IBS-C Indication OIC Indication, dosing, pharmacokinetics, and other information on the Licensed Product for use in the Field in the applicable country in the Territory based on scientific data that are positioned on appropriate prescribing information for safe and effective use of the Licensed Product in the Field in such country in the Territory.
Core Data Sheet means, with respect to a Product, a document prepared and maintained by C4T in the ordinary course of business consistent with its past practices and industry standards setting forth material information relating to safety, efficacy, indications, dosing, pharmacology, and other information concerning such Product, that serves as a global reference document and the basis for local labeling for use in Regulatory Materials and discussions with Regulatory Authorities with respect to such Product.

Related to Core Data Sheet

  • Data Sheet means an integral part of the Instructions to Consultants (ITC) Section 2 that is used to reflect specific country and assignment conditions to supplement, but not to over-write, the provisions of the ITC.

  • Safety Data Sheet means a safety data sheet within the meaning of regulation 5 of the CHIP Regulations;

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • Summary data means statistical records and reports derived from data on individuals but in which individuals are not identified and from which neither their identities nor any other characteristic that could uniquely identify the individual is ascertainable.

  • Basic Comprehensive User Guide means the Ministry document titled Basic Comprehensive Certificates of Approval (Air) User Guide” dated April 2004 as amended.

  • Data Site means an electronic password protected data site maintained by the Borrower (or by the Collateral Manager on behalf of Borrower) at Xxxxxxx Corporation, Intralinks, SyndTrak Online or any other similar electronic distribution system reasonably acceptable to the Administrative Agent.

  • Opium poppy means the plant of the species Papaver somniferum L., except its seeds.

  • Data Source Annual Fiscal Audit Report, Terms of Debt, Other Formal Notifications Received by School. Default Rubric Exceeds Standard The school has met standard for at least 3 consecutive years. Meets Standard The school is not in default of any financial obligations, and did not experience any instances of default during the fiscal year. Financial obligations include, but are not limited to, making payments to vendors and utility services on time, complying with all loan covenants, filing any reports required for maintenance of grants or philanthropic funds, meeting all tax obligations, and operating without financial judgements or property liens. Approaches Standard The school experienced one or more instances of minor default during the fiscal year (such as making late payments); however, the school is not currently in default of any financial obligations. Does Not Meet Standard School is currently in default of financial obligations.

  • Team Sheet means a form provided by the Competition on which the names of the Players taking part in a Competition match are listed.

  • Attachment point means a point on the network at which network assets are connected to assets owned by another person.

  • Appendix Information means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in:

  • Energy storage system means a system which stores energy and releases it in the same form as was input.

  • Carrier Access Billing System (“CABS”) is the system which is defined in a document prepared under the direction of the Billing Committee of the OBF. The CABS document is published by Telcordia in Volumes 1, 1A, 2, 3, 3A, 4 and 5 as Special Reports SR-OPT-001868, SR-OPT-0011869, SR-OPT-001871, SR-OPT- 001872, SR-OPT-001873, SR-OPT-001874, and SR-OPT-001875, respectively, and contains the recommended guidelines for the billing of access and other connectivity services. Sprint’s carrier access billing system is its Carrier Access Support System (CASS). CASS mirrors the requirements of CABS.

  • Master Batch Record or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • Customer Proprietary Network Information (“CPNI”) is as defined in the Act.

  • Standard Specifications means a compilation in book form of specifica- tions approved for general application and repetitive use;

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Host At Destination means the person with whom the Insured is sharing prearranged overnight accommodations in the host's home.

  • Policy Web Pages means the web pages available at xxx.xxxxxx.xxx.xx.xx/xxxxxxxxxxxx, and at xxx.xxxxxx.xxx.xx.xx/xxxxxxxxxxxxxxx or such other URLs or Web pages as the LHIN or the Ministry may advise from time to time. Capital policies can be found at Xxxx://xxx.xxxxxx.xxx.xx.xx/english/providers/program/ltc_redev/awardeeoperator.html.

  • Work Schedule means the approved order and timeline for how the requirements of this contract, including Work on individual Units or groups of Units, will be fulfilled by the Contractor.

  • Standard Materials means all Materials not specified as Custom Materials.

  • Network Data Mover (NDM) or “Connect Direct” means the industry standard protocol for transferring information electrically.

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • Area source means any stationary source of hazardous air pollutants that is not a major source as defined in rule 567—22.100(455B).

  • the data subject s consent' shall mean any freely given specific and informed indication of his wishes by which the data subject signifies his agreement to personal data relating to him being processed.

  • Contractor information system means an information system belonging to, or operated by or for, the Contractor.