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 a report on the safety experience of a drug at defined times, after the drug is registered;
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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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Examples of Periodic Safety Update Report in a sentence

  • As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).

  • The marketing authorisation holder (MAH) shall provide the competent authority with a consolidated version of the file in respect of quality, safety and efficacy including an evaluation of data contained in suspected adverse reaction reports, Periodic Safety Update Report (PSUR) data (if applicable) and any relevant new information affecting the benefit/risk of the product together with a list of all variations introduced since the MA was granted.

  • 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.

  • As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).

  • The study protocol, study status, and report(s) will be included in regulatory communications in line with the risk management plan, Periodic Safety Update Report (PSUR), and other regulatory milestones and requirements.Publication and Communication Plan.

  • As per the CHMP guideline on the risk management systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).

  • Notwithstanding the foregoing, Lilly shall not be obligated to provide Zosano copies of any Lilly Forteo® Regulatory Filings to the United States Food & Drug Administration for more than the past five (5) years and such copies shall be limited to the IND Annual Report, Developmental Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR).

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

  • Where applicable, the Client must schedule and submit annually all additional reports such as the Summary of Safety and Clinical Performance Report (SSCPR), the Periodic Safety Update Report (PSUR) and the Post Market Clinical Follow Up Report (PMCFUR).

  • The evaluator also provided specific discussion on several matters, including:UsageSince April 2009, there had been XXXXX units sold in Australia and approximately XXXXX patients may have been exposed (the evaluator noted that this figure allowed for stock still in the supply chain).Australian adverse reaction reportingStated that the applicant received one report that resulted in “case line listing” in the Periodic Safety Update Report (PSUR) in Australia.


More Definitions of Periodic Safety Update Report

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 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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Periodic Safety Update Report means a report containing update safety data pertaining to a registered health product and a scientific evaluation report regarding the benefits and risks of the health product;
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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 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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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.

  • 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.

  • Periodic Updation means steps taken to ensure that documents, data or information collected under the CDD process is kept up-to-date and relevant by undertaking reviews of existing records at periodicity prescribed by the Reserve Bank.

  • ESDM Report means the Emission Summary and Dispersion Modelling Report prepared in accordance with the Procedure Document by Envision Compliance Ltd. and dated March 19, 2008 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.

  • CREFC® Loan Periodic Update File The data file in the “CREFC® Loan Periodic Update File” 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.

  • 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, 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.

  • 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

  • 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.

  • 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® Servicer Watch List/Portfolio Review Guidelines As of each Determination Date a report, including and identifying each Performing Serviced Loan satisfying the “CREFC® Portfolio Review Guidelines” approved from time to time by the CREFC® in the “CREFC® Servicer Watch List” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form (including other portfolio review guidelines) for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • 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.

  • 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.

  • CREFC® REO Liquidation Report Template A report substantially in the form of, and containing the information called for in, the downloadable form of the “REO Liquidation Report Template” available as of the Closing Date on the CREFC® 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 CREFC® for commercial mortgage securities transactions generally.

  • 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 7, 2019 and effective December 31, 2018.

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

  • CREFC® Loan Modification Report Template A report substantially in the form of, and containing the information called for in, the downloadable form of the “Loan Modification Report Template” available as of the Closing Date on the CREFC® 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 CREFC® for commercial mortgage securities transactions generally.

  • 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.

  • CMSA REO Status Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "REO Status 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 securities transactions generally.

  • 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.