Periodic Safety Update Report definition

Periodic Safety Update Report means a report prepared to meet the requirements of the 2001 Directive;
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Periodic Safety Update Report means, subject to any amendment pursuant to the ICH from time to time, a safety report generated at set times and manner according to ICH 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;
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Periodic Safety Update Report means a report on the safety experience of a drug at defined times, after the drug is registered (SI-regulation);
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Examples of Periodic Safety Update Report in a sentence

  • X Periodic Safety Update Report PSURs (Production) Vifor is responsible for the preparation of the PSUR in ICH format.

  • Annual summary reports may be submitted in the form of a Periodic Safety Update Report (PSUR) as defined by ICH E2C(R1) guideline.

  • Periodic Safety Update Report (PSUR) Periodic safety update reports mean the periodical reports containing the records referred to in Article 104 of Directive 2001/83/EC and in Article 24(3) of Regulation (EC) No 726/2004.

  • Furthermore these ADRs will be included in the Periodic Safety Update Report (PSUR).

  • Aggregate Safety Reports Periodic Safety Update Report (PSUR), Summary Bridging Report, Addendum Report (ICH E2C (R1)) Periodic benefit-risk evaluation report (PBRER) (ICH E2C (R2)) PSUR (GVP, Module VII) Causality assessment Safety information should be exchanged independent of the causal relationship.


More Definitions of Periodic Safety Update Report

Periodic Safety Update Report or “PSUR” means a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points post-market authorization.
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Periodic Safety Update Report or “PSUR” shall mean a report of Adverse Events in the format required by applicable legislation in the applicable Territory prepared and submitted by a Party in respect of the Product on a periodic basis to Regulatory Authorities, and which shall include updates on urgent safety matters or issues, major signal detection and/or evaluation, and changes in efficacy.
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Periodic Safety Update Report means a periodic record intended to update the medicinal product safety data and to submit it according to the procedure established by the State Medicines Control Agency.
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Periodic Safety Update Report or “PSUR” means the periodical reports containing the records referred to in Articles 107b–107g of Directive 2001/83/EC (as amended), i.e. the format and content for providing an evaluation of the risk-benefit balance of a medicinal product for submission at defined time points during the post-authorisation phase. If the periodical report is a periodic benefit-risk evaluation report (PBRER) with greater emphasis on benefit than the PSUR, the PBRER should follow the format of the ICH guideline E2C on periodic benefit-risk evaluation report (PBRER). PSUR finalized and submitted by XXXXXXX should follow the format given in applicable legislation in the Territory.
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Related to Periodic Safety Update Report

  • 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.

  • 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.

  • Payment Date Report has the meaning assigned to such term in Section 8.07(b).

  • 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.

  • Technical Report means a report prepared and filed in accordance with this Instrument and Form 43-101F1 Technical Report that includes, in summary form, all material scientific and technical information in respect of the subject property as of the effective date of the technical report; and

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

  • 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.

  • 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;

  • Variance Report shall have the meaning assigned to such term in Section 5.01(g).

  • 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.

  • Benchmarking Report means the report produced by the Supplier following the Benchmark Review and as further described in this Framework Schedule 7;

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

  • Physical Conditions Report means, with respect to the Property, a report prepared by a company satisfactory to Lender regarding the physical condition of the Property, satisfactory in form and substance to Lender in its sole discretion, which report shall, among other things, (a) confirm that the Property and its use complies, in all material respects, with all applicable Legal Requirements (including, without limitation, zoning, subdivision and building laws) and (b) include a copy of a final certificate of occupancy with respect to all Improvements on the Property.

  • Geotechnical report or "geotechnical analysis" means a scientific study or evaluation conducted by a qualified expert that includes a description of the ground and surface hydrology and geology, the affected land form and its susceptibility to mass wasting, erosion, and other geologic hazards or processes, conclusions and recommendations regarding the effect of the proposed development on geologic conditions, the adequacy of the site to be developed, the impacts of the proposed development, alternative approaches to the proposed development, and measures to mitigate potential site-specific and cumulative geological and hydrological impacts of the proposed development, including the potential adverse impacts to adjacent and down-current properties. Geotechnical reports shall conform to accepted technical standards and must be prepared by qualified professional engineers or geologists who have professional expertise about the regional and local shoreline geology and processes.

  • Periodic Billing Requirement means, for any Remittance Period, the aggregate amount of Charges calculated by the Servicer as necessary to be billed during such period in order to collect the Periodic Payment Requirement on a timely basis.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.