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”).

  • Company Core Data Sheet (CCDS) PROPESS/CERVIDIL vaginal delivery system 10 mg, Company Core Data Sheet-5971, ver.

  • 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.

  • Except as set forth in Section 3.18(j) of Seller’s Disclosure Schedule, the consummation of the Contemplated Transactions will not result in the payment, vesting or acceleration of any benefit under or in connection with any Company Plan or Other Benefit Obligation.

  • The Reference Safety Information (usually the Company Core Data Sheet (CCDS) or the Company Core Safety Information (CCSI)) should still be used for preparation of the PSUR.

  • 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.

  • 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).

  • 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.


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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Related to Company 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.

  • 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 EU-U.S. Privacy Shield and Swiss-U.S. Privacy Shield Framework self-certification program operated by the U.S. Department of Commerce and approved by the European Commission pursuant to Decision C(2016)4176 of 12 July 2016 and by the Swiss Federal Council on January 11, 2017 respectively.

  • 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 published scientific study in a journal or other publication in which original manuscripts have been published only after having been critically reviewed for scientific accuracy, validity and reliability by unbiased independent experts, and that has been determined by the international committee of medical journal editors to have met the uniform requirements for manuscripts submitted to biomedical journals. Peer-reviewed medical literature does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or health carrier.

  • 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 (i) data and information regarding each Fund and the shareholders and shareholder accounts of each Fund which is inputted into the Licensed System and the content of records, files and reports generated from such data and information by the Licensed System, and (ii) Company 22c-2 Data (as defined in Section 6.15(a) of this Schedule C).

  • 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.