Periodic Safety Report definition

Periodic Safety Report means a safety report generated at set times and in accordance with FDA guidelines for the purpose of demonstrating the current risk/benefit analysis of the Shire Product according to present knowledge and produced to provide a historical perspective on the safety issues surrounding the Shire Product.
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Periodic Safety Report means a safety report generated at set times and in accordance with FDA guidelines for the purpose of demonstrating the current risk/benefit analysis of the Product according to present knowledge and produced to provide a historical perspective on the safety issues surrounding the Product. “Product” has the meaning given to it in the Acquisition and License Agreement. “Reference Safety Information” means the recognized Adverse Reactions to the Product contained in all or any one of Shire’s Developmental Core Safety Information (DCSI) in an investigator’s brochure, Shire’s Company Core Safety Information (CCSI) in a marketed product Company Core Data Sheet (CCDS) and Shire’s official local product labeling (including the local Summary of Product Characteristics (SPC)).
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Periodic Safety Report means a periodic report for marketed Licensed Products in Japan. Such reports are required semiannually for the first two (2) years after Regulatory Approval in Japan, then annually thereafter.
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Examples of Periodic Safety Report in a sentence

  • BIOCODEX sends an electronic copy of the Periodic Safety Report to CMS, in an appropriate time for local submission by CMS in its Territory.

  • For planning purpose, COMPANY and BIOCODEX should regularly liaise to inform each other early enough of any Periodic Safety Report to be authored and submitted as part of routine PSUR submission cycle, marketing authorization renewal or ad-hoc Competent Authority request.

  • Information contained in Periodic Safety Report is the property of the Party generating them and proprietary rights will be respected.

Related to Periodic Safety Report

  • Rapidly report means within 72 hours of discovery of any cyber incident.

  • MI Report means a report containing Management Information submitted to the Authority in accordance with Framework Schedule 8 (Management Information);

  • SOS Reports means the official reports from the Secretaries of State of each Collateral State, the state where Borrower’s chief executive office is located, the state of Borrower’s formation and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.

  • 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.

  • GLJ Report means the independent engineering reserves evaluation of certain oil, NGL and natural gas interests of the Company prepared by GLJ dated February 11, 2022 and effective December 31, 2021.

  • Periodic Reports means the Company’s (i) Annual Reports on Form 10-K, (ii) any Quarterly Report to be filed on Form 10-Q and (iii) all other financial reports required to be filed by the Company with the Commission under applicable laws and regulations (including, without limitation, Regulation S-K) for so long as any amounts are outstanding under this Debenture or any Other Debenture; provided that all such Periodic Reports shall include, when filed, all information, financial statements, audit reports (when applicable) and other information required to be included in such Periodic Reports in compliance with all applicable laws and regulations.

  • Third Party Reports With respect to any Mortgaged Property, the related Appraisal, Phase I environmental report, Phase II environmental report, seismic report or property condition report, if any.

  • ESDM Report means the Emission Summary and Dispersion Modelling Report, dated June 12, 2009, prepared in accordance with the Procedure Document by Golder Associated Ltd. and submitted in support of the application, and includes any amendments to the ESDM Report listed in Schedule A and all up-dated ESDM Reports prepared as required by the Documentation Requirements conditions of this Certificate.

  • Periodic Report means the Company’s quarterly report on Form 10-Q or annual report on Form 10-K, as applicable.

  • Monthly Reports shall have the meaning specified in Section 5.16(b) of the Indenture.

  • Feasibility Report means a detailed written report of the results of a comprehensive study on the economic feasibility of placing the Property or a portion thereof into Commercial Production and shall include a reasonable assessment of the mineral ore reserves and their amenability to metallurgical treatment, a description of the work, equipment and supplies required to bring the Property or a portion thereof into Commercial Production and the estimated cost thereof, a description of the mining methods to be employed and a financial appraisal of the proposed operations supported by an explanation of the data used therein;

  • Day reporting means a program of enhanced supervision

  • ORSA summary report means a confidential high-level summary of an insurer or insurance group's own risk and solvency assessment.

  • Rapid(ly) report(ing means within 72 hours of discovery of any cyber incident.

  • Inspection Report means the report delivered by the Master Servicer or the Special Servicer, as the case may be, substantially in the form of Exhibit L hereto.

  • MI Reporting Template means the form of report set out in the Annex to Framework Schedule 8 (Management Information) setting out the information the Supplier is required to supply to the Authority;

  • Medicare cost report means CMS-2552-10, the cost report for electronic filing of

  • health and safety file means a file, or other record containing the information in writing required by these Regulations "health and safety plan" means a site, activity or project specific documented plan in accordance with the client's health and safety specification;

  • Survey Report means a report of the results of a Survey, containing the information set out in clause 12.4 and Schedule 6.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Compliance Statement is that certain statement in the form attached hereto as Exhibit B.

  • Acoustic Assessment Report means the report, prepared in accordance with Publication NPC-233 and Appendix A of the Basic Comprehensive User Guide,by HGC Engineering and dated August 22, 2008 submitted in support of the application, that documents all sources of noise emissions and Noise Control Measures present at the Facility and includes all up-dated Acoustic Assessment Reports as required by the Documentation Requirements conditions of this Certificate to demonstrate continued compliance with the Performance Limits following the implementation of any Modification.