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 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. ​

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.

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.

• The parties’ obligations hereunder shall terminate on the expiration date of this Contract with the exception of those obligations that accrued prior to the expiration date.

• 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.

• 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”).

• 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.

• 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 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.

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, 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.

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.