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

  • 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”).

  • 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.

  • 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.

  • Contended that the Company Core Data Sheet (CCDS) included in the XXXXX PSUR was even less comprehensive.

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

  • Promptly after the Effective Date, the Parties shall coordinate regarding the process for the preparation of the Company Core Data Sheet (and any updates thereto) for the Product for submission to the JSC for review, discussion and approval.

  • Meda will be responsible for maintaining the Company Core Safety Information (“CCSI”), as included in the Company Core Data Sheet (“CCDS”), in the Territory.

  • They are in the process of updating their Company Core Data Sheet (CCDS) and working with health authorities to update labeling appropriately.

  • 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.

  • 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).


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) 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 the securities and shall, ordinarily including but not 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 Company-Licensed Data, Company-Owned Data and Personal Data.

  • 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).

  • Produced Material means records, software and other material, whether complete or not, that, as a result of this Agreement, are produced or provided by the Contractor or a Subcontractor and includes the Incorporated Material;

  • 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: –

  • SAP Materials means any materials (including statistical reports) provided, developed or made available by SAP (independently or with Customer’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Professional Services to Customer. SAP Materials do not include the Customer Data, Customer Confidential Information or the Cloud Service. SAP Materials may also be referred to in the Agreement as “Cloud Materials”.

  • 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. 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.