Company Core Data Sheet definition

Company Core Data Sheet means the global reference labeling document used to direct the content of country-specific labeling for Licensed Products.
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Company Core Data Sheet is defined in Section 5.2(a).
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Company Core Data Sheet or “CCDS” means, a document prepared by the Marketing Authorization Holder containing, in addition to safety information, material related to indications, dosing, pharmacology and other information concerning the Product (see GVP Annex IV, ICH-E2C(R2) Guideline).
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Examples of Company Core Data Sheet in a sentence

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

  • 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”).

  • 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.

  • Novo Nordisk assessment of expectedness is performed according to the following reference documents: IB17 and the Company Core Data Sheet (CCDS), current version or updates hereof.

  • For example, consider an MAH that is preparing a PBRER for a corticosteroid that can be used to manage asthma and chronic obstructive airway disease (inhaler), rhinitis (intranasal spray), Crohn’s Disease (oral) and ulcerative colitis (suppository) — in this situation, the MAH should specify a single reference product information document, which in practice is often the Company Core Data Sheet (CCDS).

  • Moderate Pgp inhibitors: (Itraconazole, clarithromycin, telithromycin, erythromycin, amiodarone) ValsartanTwo drug-drug interactions were identified for valsartan which are currently listed in the Company Core Data Sheet: potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium and lithium DDI.Potential drug interactions with atorvastatin is listed in the SmPC (Sect.

  • 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.

  • For this purpose a tabulation should be added to the cover letter.The Reference Safety Information used for preparation of the PSUR usually is the Company Core Data Sheet (CCDS) or the Company Core Safety Information (CCSI).

  • Remember changes to the Company Core Data Sheet (CCDS) will generally not be available to HCPs and patients unless reflected in product labelling, but changes to the CCDS are not automatically applicable to the product labelling without assessment of the supporting data.

  • If companies submit their Company Core Data Sheet, this is recommended to be provided in section 5.3.6, Post Marketing Experience.


More Definitions of Company Core Data Sheet

Company Core Data Sheet means a document prepared by the marketing authorization holder for a product that contains safety information as well and information relating to indications, dosing, pharmacology and other applicable information, in each case, with respect to such product.
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Company Core Data Sheet means the global reference labelling document used to direct the content of country-specific labelling for Licensed Products;
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Related to Company Core Data Sheet

  • Data Sheet means an integral part of the Instructions to Consultants (ITC) Section2thatisusedtoreflect specific assignment conditions to supplement, but not to over-write, the provisions of the ITC.

  • 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.

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

  • Company Content means all editorial content, graphics, data, and information contained in the Report or on the Website, any portion thereof, including the selection, coordination, and arrangement of the editorial content, graphics, data, and information on the Website, and the hierarchy of the Website.

  • Unpublished Price Sensitive Information means any information, relating to a company or its securities, directly or indirectly, that is not generally available which upon becoming generally available, is likely to materially affect the price of the securities and shall, ordinarily including but not restricted to, information relating to the following: –

  • Unpublished Price Sensitive Information (UPSI means any information, relating to a Company or its Securities, directly or indirectly, that is not generally available which upon becoming generally available, is likely to materially affect the price of Securities of the Company and shall, ordinarily include but not be restricted to, information relating to the following:

  • Data Room Information means the information and documents listed in the index of documents contained in the Data Site attached to the Company Disclosure Letter;

  • Company Financial Information As defined in Section 2(a)(ii).

  • Privacy Shield means the European Union (EU) -U.S. and Switzerland – U.S. Privacy Shield frameworks.

  • 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.

  • Peer-reviewed medical literature means a scientific study published only after having been critically

  • 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:

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

  • Company Data means all data collected, generated, or received in connection with the marketing, delivery, or use of any Company Product, including Personal Data.

  • Indigenous Peoples Safeguards means the principles and requirements set forth in Chapter V, Appendix 3, and Appendix 4 (as applicable) of the SPS;

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

  • Virtual source means a point from which radiation appears to originate.

  • Company Reports has the meaning set forth in Section 3.08(a).

  • Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

  • Unpublished price sensitive information or UPSI means any information, relating to a company or its securities, directly or indirectly, that is not generally available which upon becoming generally available, is likely to materially affect the price of the securities and shall, ordinarily including but not restricted to, information relating to the following: –

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

  • Contractor attributional/proprietary information means information that identifies the contractor(s), whether directly or indirectly, by the grouping of information that can be traced back to the contractor(s) (e.g., program description, facility locations), personally identifiable information, as well as trade secrets, commercial or financial information, or other commercially sensitive information that is not customarily shared outside of the company.

  • Contractor attributional/proprietary information means information that identifies the contractor(s), whether directly or indirectly, by the grouping of information that can be traced back to the contractor(s) (e.g., program description, facility locations), personally identifiable information, as well as trade secrets, commercial or financial information, or other commercially sensitive information that is not customarily shared outside of the company.

  • Data Safeguards means the highest industry-standard safeguards (including administrative, physical, technical, and procedural safeguards) against the destruction, loss, misuse, unauthorized disclosure, or alteration of the JBE Data or Confidential Information, and such other related safeguards that are set forth in Applicable Laws, a Statement of Work, or pursuant to JBE policies or procedures.

  • 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.

  • 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.