Core Data Sheet definition

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. ​
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Core Data Sheet means a document setting forth information relating to safety, efficacy, indications, dosing, pharmacology, and other information concerning the Product.
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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.
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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.

  • REFERENCE SAFETY INFORMATION NORGINE is responsible for the preparation and maintenance of an up to date Company Core Data Sheet (“CCDS”) including the Company Core Safety Information (“CCSI”).

  • Pfizer maintains that determining whether the Core Data Sheet and the U.S. label are consistent is not merely a comparison of words used but is a medical judgment as to whether the essential message regarding risk is conveyed appropriately considering the relevant governmental regulations and the physician practices in a particular country.

  • Genmab and SGI hereby agree to establish a Core Data Sheet working group (the “CDS Working Group”) within [*] days after the Effective Date.

  • The Core Data Sheet and any amendments thereto must be approved by the JSC.

  • CENTREXION shall satisfy and perform any and all global pharmacovigilance responsibilities, such as but not limited to global safety database maintenance, global literature screening, periodic safety report generation (e.g., the Development Safety Update Reports (“DSUR”)), signal detection, risk management, Company Core Data Sheet (“CCDS”) maintenance, management of authority requests, arising under any applicable laws as of the execution date of this agreement with regard to the Product.

  • The JRT, together with the CDS Working Group, will (i) review a draft Core Data Sheet prepared by SGI and any amendments thereto proposed by SGI, and (ii) agree on a proposed version of the Core Data Sheet to submit to the JDC.

  • Following Governmental Approval, Meda will be responsible for (i) maintaining the Company Core Safety Information (“CCSI”), as included in the Company Core Data Sheet (“CCDS”), in the Territory and (ii) maintaining the CCSI, as included in the Package Insert/Prescribing Information (“PI”), in the United States.

  • Each Party shall, as soon as reasonably practicable after the same become available (to the extent that such Party is undertaking any preparation of the same), provide the other Party with copies of the Core Data Sheet (“CDS”), approved local prescriber, and patient-directed, labeling that are proposed or approved for the Commercialization of the Finished Product and Development of the Bulk Product in the Field in the Territory.

  • The Clinical Coordinator (or his deputy) will assess the potential expectedness of each SAR using the Merck Schering-Plough (MSP) Core Data Sheet for ezetimibe/simvastatin and the Merck Core Data Sheet for simvastatin.


More Definitions of Core Data Sheet

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.
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Core Data Sheet means the internal Amgen-developed document that sets forth the efficacy and safety profile for a Product.
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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.
Sample 1
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.
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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.
Sample 1
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 ...
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Related to Core Data Sheet

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  • 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.

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  • 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. Exceeds Standard The school has met standard for at least 3 consecutive years. 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.

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

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  • 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 Funder 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 a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • 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.

  • SAP Training Catalogue means the catalogue published by SAP containing details of SAP training courses and services.