Data Lock Point definition

Data Lock Point means, subject to any amendment pursuant to the ICH from time to time, the last date of the period for which information is collected in relation to a Periodic Safety Update Report;
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Data Lock Point a restriction of the use of the medicinal product or its suspension. “ICSR” shall mean the document summarizing all available information related to an individual case safety report at a specific point of time. An Individual Case Safety Report (ICSR) is considered valid as soon as the four minimal elements are cumulatively available:
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Data Lock Point means for a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in a PSUR.
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Examples of Data Lock Point in a sentence

  • Part four is an open-ended question asking their general views or comments on CCA.

  • In the event of a Shelf Registration, the Company shall bear or reimburse the Holders of the Securities covered thereby for an amount not to exceed $25,000 for the reasonable fees and disbursements of one firm of counsel designated by the Holders of a majority in principal amount of the Initial Securities and the Accredited Investor Securities covered thereby to act as counsel for the Holders of the Initial Securities and the Accredited Investor Securities in connection therewith.

  • CMS shall request the PSUR from NORGINE at least SEVENTY (70) Days in advance of the Data Lock Point (“DLP”).

  • For purposes of identifying patterns of use outside the terms of the reference product information, the MAH should use the appropriate sections (e.g., approved indication[s], contraindication[s]) of the reference product information that was in effect at the Data Lock Point (DLP) of the PBRER.

  • Any information on potentially important safety findings that arise after the Data Lock Point for DSUR while the DSUR is in preparation should be provided to Collaborator as soon as feasible.

  • Collaborator will submit the DSUR no later than 60 calendar days after the Data Lock Point for DSUR.

  • The Data Lock Point for DSUR will be the last day of the one-year reporting period (the 5th day of December).

  • ICD will provide the necessary clinical and/or nonclinical data (not to include any IPI) to enable preparation of the DSUR to Collaborator within one week of the Data Lock Point for DSUR.

  • The tool, which is expected to simplify and optimise this process, is planned to be used in the coming years on a subset of more than 1,000 entries for which a PSUR frequency of 13 years and a Data Lock Point (DLP) of 2025 was allocated at the time of the creation of the EURD list.

  • Where it has not been possible to link with the holder of the DIBD for the sake of clarity, the Data Lock Point (DLP) will be taken as the anniversary of the Clinical Trials Authorisation.

Related to Data Lock Point

  • Data Log means a complete record of all Data Interchanged representing the Messages and their Associated Data between the parties;

  • 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.

  • Data Processing Lease means any lease or licensing agreement, binding on the Failed Bank as of Bank Closing, the subject of which is data processing equipment or computer hardware or software used in connection with data processing activities. A lease or licensing agreement for computer software used in connection with data processing activities shall constitute a Data Processing Lease regardless of whether such lease or licensing agreement also covers data processing equipment.

  • Surplus Interconnection Customer means either an Interconnection Customer whose Generating Facility is already interconnected to the PJM Transmission System or one of its affiliates, or an unaffiliated entity that submits a Surplus Interconnection Request to utilize Surplus Interconnection Service within the Transmission System in the PJM Region. A Surplus Interconnection Customer is not a New Service Customer.

  • Data Processing Addendum means Sprinklr’s Data Processing Addendum, located at www.sprinklr.com/legal

  • Surplus Interconnection Service means any unneeded portion of Interconnection Service established in an Interconnection Service Agreement, such that if Surplus Interconnection Service is utilized, the total amount of Interconnection Service at the Point of Interconnection would remain the same.

  • Generation Interconnection Customer means an entity that submits an Interconnection Request to interconnect a new generation facility or to increase the capacity of an existing generation facility interconnected with the Transmission System in the PJM Region.

  • Data Processing Equipment means any equipment, computer hardware, or computer software (and the lease or licensing agreements related thereto) other than Personal Computers, owned or leased by the Failed Bank at Bank Closing, which is, was, or could have been used by the Failed Bank in connection with data processing activities.

  • Network Data Mover (NDM) or “Connect Direct” means the industry standard protocol for transferring information electrically.

  • data user means a natural or legal person who has lawful access to certain personal or non-personal data and is authorised to use that data for commercial or non-commercial purposes;

  • Development Location Point means a single point selected by the Applicant on the proposed Development site that is located within 100 feet of a residential building existing or to be constructed as part of the proposed Development. For a Development which consists of Scattered Sites, this means a single point on the site with the most units that is located within 100 feet of a residential building existing or to be constructed as part of the proposed Development.

  • Demarcation Point means the point where Qwest owned or controlled facilities cease, and CLEC, End User Customer, premises owner or landlord ownership or control of facilities begin. "Designed, Verified and Assigned Date" or "DVA" means the date on which implementation groups are to report that all documents and materials have been received and are complete.

  • Data Processing Agreement means the data processing agreement located at xxx.xxxxxx.xxx/[countrycode]/legal/dpa, where “[countrycode]” means the two-letter abbreviation for the country where your Stripe Account is located.

  • Central fill pharmacy means a pharmacy contracting with an originating pharmacy, or having the same owner as an originating phar- macy, that provides centralized prescription filling on behalf of the originating pharmacy pursuant to these rules.

  • Interconnection Activation Date means the date that the construction of the joint facility Interconnection arrangement has been completed, trunk groups have been established, joint trunk testing is completed and trunks have been mutually accepted by the Parties.

  • Interconnection Service Agreement means an agreement among the Transmission Provider, an Interconnection Customer and an Interconnected Transmission Owner regarding interconnection under Tariff, Part IV and Tariff, Part VI.

  • END USER CUSTOMER LOCATION means the physical location of the premises where an End User makes use of the telecommunications services.

  • Attachment point means a point on the network at which network assets are connected to assets owned by another person.

  • Net metering customer means a customer of the electric distribution company

  • Data Use Agreement means the agreement incorporated into the Contract to facilitate creation, receipt, maintenance, use, disclosure or access to Confidential Information.

  • Generation Interconnection Agreement means the large generator interconnection agreement to be entered into separately between Seller and Interconnection Provider concerning the Interconnection Facilities.

  • Data Center(s) means the site or sites at which the Software will be hosted to provide the Authorized Services to Customers. Such site or sites shall at all times be owned or controlled by the Provider.

  • Transmission Interconnection Customer means an entity that submits an Interconnection Request to interconnect or add Merchant Transmission Facilities to the Transmission System or to increase the capacity of Merchant Transmission Facilities interconnected with the Transmission System in the PJM Region or an entity that submits an Upgrade Request for Merchant Network Upgrades (including accelerating the construction of any transmission enhancement or expansion, other than Merchant Transmission Facilities, that is included in the Regional Transmission Expansion Plan prepared pursuant to Operating Agreement, Schedule 6).

  • Interconnection Customer means a Generation Interconnection Customer and/or a Transmission Interconnection Customer.

  • Synchronous interaction means a real-time interaction between a patient and a health care provider for telehealth located at a distant site.

  • Office of the Interconnection Control Center means the equipment, facilities and personnel used by the Office of the Interconnection to coordinate and direct the operation of the PJM Region and to administer the PJM Interchange Energy Market, including facilities and equipment used to communicate and coordinate with the Market Participants in connection with transactions in the PJM Interchange Energy Market or the operation of the PJM Region.