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

  • The periodicity of the Periodic Safety Report will be according to the International Birth Date of the Shire Product.

  • In addition, for any other research data acquired after drug approval related to indications and/or safety of the drug concerned, a Periodic Safety Report submitted near the date of the reexamination application should be attached.

  • This prohibition on referring to any Periodic Safety Report shall not apply to any information contained in those Periodic Safety Reports which would in the ordinary course of business be referred to in advertising or promotional materials (such as data to substantiate claims made in respect of a Medicinal Product).

  • The periodicity of the Periodic Safety Report will be according to the International Birth Date of the Product.

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

  • Shire shall prepare and submit to Duramed pursuant to Section 7.6 the Periodic Safety Report for the Product in the Territory, according to its internal standard operating procedures and in the format as detailed in 21CFR 314.

  • In addition, when PBRER prepared by foreign companies should be appended to the Japanese Periodic Safety Report together with the information obtained in drug use-results survey in the section "Future Safety Measures Planned on the Basis of Surveillance Results" in the Periodic Safety Report, and submitted, or the contents of the PBRER should be compiled and incorporated into the Japanese Periodic Safety Report and submitted.

  • Submitting Periodic Safety Report as a single file (with bookmarks, table of contents and hyperlinks) is acceptable.

  • Likewise, Toyama agrees to provide Cempra a copy of the Periodic Safety Report from Toyama’s clinical studies and/or periodic post-marketing safety report in the Territory at the time of submission to Regulatory Authorities.

  • Commissioner Perelman said she liked the emphasis of reaching out to the homeless community.

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, Chief Executive Office State and the Borrower State 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.

  • Sustainability Report the annual non-financial disclosure report prepared in accordance with the Standard for Sustainability Reporting publicly reported by the Borrowers and published on an Internet or intranet website to which each Bank and the Administrative Agent have been granted access free of charge (or at the expense of the Borrowers).

  • 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 all of the Company’s reports required to be filed by the Company with the Commission under applicable laws and regulations (including, without limitation, Regulation S-K), including annual reports (on Form 10-K), quarterly reports (on Form 10-Q), and current reports (on Form 8-K), for so long as any amounts are outstanding under this Note or any Other Note; 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 prepared in accordance with the Procedure Document by Envision Compliance and dated July 3, 2007 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.

  • Operating Statement Analysis Report format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CREFC® Operating Statement Analysis Report The monthly report in the “Operating Statement Analysis Report” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • 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.

  • CMSA Operating Statement Analysis Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Operating Statement Analysis Report" available as of the Closing Date on the CMSA Website or in such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage-backed securities transactions generally.

  • Feasibility Report means a detailed report, in form and substance sufficient for presentation to arm's length institutional lenders considering project financing, showing the feasibility of placing any part of the Property into commercial production as a Mine and shall include a reasonable assessment of the various categories of ore reserves and their amenability to metallurgical treatment, a complete description of the work, equipment and supplies required to bring such part of the Property 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 and including at least the following: (i) a description of that part of the Property to be covered by the proposed Mine; (ii) the estimated recoverable reserves of Minerals and the estimated composition and content thereof; (iii) the proposed procedure for development, mining and production; (iv) results of ore amenability treatment tests (if any); (v) the nature and extent of the facilities proposed to be acquired, which may include mill facilities if the size, extent and location of the ore body makes such mill facilities feasible, in which event the study shall also include a preliminary design for such mill; (vi) the total costs, including capital budget, which are reasonably required to purchase, construct and install all structures, machinery and equipment required for the proposed Mine, including a schedule of timing of such requirements; (vii) all environmental impact studies and costs of implementation; (viii) the period in which it is proposed the Property shall be brought to commercial production; and (ix) such other data and information as are reasonably necessary to substantiate the existence of an ore deposit of sufficient size and grade to justify development of a mine, taking into account all relevant business, tax and other economic considerations including a cost comparison between purchasing or leasing and renting of facilities and equipment required for the operation of the Property as a Mine.

  • Day reporting means a program of enhanced supervision

  • ORSA summary report means a confidential high-level summary of an insurer or insurance group's ORSA.

  • 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.

  • CMSA Loan Periodic Update File means the monthly report substantially in the form of, and containing the information called for in, the downloadable form of the "Loan Periodic Update File" available as of the Closing Date on the CMSA Website, or such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage securities transactions generally.

  • 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.