Spontaneous Reports definition

Spontaneous Reports means any unsolicited communication to any Party describing an AE or a Special Situation, including, without limitation those received from consumers, health professionals, Internet sources, Regulatory Authorities, reports received from non-company registries, regulatory databases, literature reports or other situations where there is unstructured or unsolicited collection.
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Spontaneous Reports from Patient Support Programs or Marketing Research Programs includes all Adverse Reactions reported from any program designed to encourage the HCP or consumer to voluntarily contact the company for educational material or support. Any program which does not systematically include any questions that request safety information in response.
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Spontaneous Reports an unsolicited communication by a healthcare professional or consumer to a company, the local regulatory authority or other organization (e.g. the World Health Organization, a regional centre, a poison control centre) that describes one or more adverse reactions in a patient who was given one or more medicinal Product(s) and that does not derive from a study or any organized data collection scheme. Suspected Adverse Event: an AE which is thought to be related to the medicinal drug is “suspected”. In general, all spontaneous reports are considered suspected for expediting purposes. Unexpected Adverse Drug Reaction: an Adverse Drug Reaction where the nature, frequency, severity, specificity or outcome is not consistent with the term or description used in the Investigator’s Brochure or local/regional product information (i.e. SmPC, PIL, labels or package insert) labelling (PIL or SmPC). An otherwise expected ADR with a fatal outcome should be considered unexpected unless the appropriate product label specifically states that the ADR might be associated with a fatal outcome. Valid Case: a case which includes the minimum information required for all reporting purposes, consisting of an identifiable reporter (source), an identifiable patient, a suspected medicinal product(s) and an AE/ADR.
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Examples of Spontaneous Reports in a sentence

  • Liu, Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease- Modifying Antirheumatic Drugs for Rheumatoid Arthritis., Fron- tiers in pharmacology 9 (2018) 875.

  • Paw S.G. Petersen, and Ebba Holme Hansen, Global Patterns of Adverse Drug Reactions Over a Decade: Analyses of Spontaneous Reports to VigiBase, Drug Saf 2012; 35 (12): 1171- 1182.

  • SRs (Spontaneous Reports) and literature reports concerning the Products are outside the scope of this current Pharmacovigilance Agreement.

  • This Section 3 applies solely to Spontaneous Reports for the Medicinal Products from all sources received by each Party and reports for the Medicinal Products from all other sources except Clinical Studies.

  • This Agreement covers: • all Spontaneous Reports and/or Solicited Reports of Adverse Events in relation to the Product; • all Serious Adverse Reactions arising from clinical trials and post-marketing surveillance (PMS) with the Product; • all information required for periodic reporting in relation to the Product; and • the reporting of all other information as required by Regulatory Authorities for the Product.

  • ICH Guidance E2D; Post-approval Safety Data Management: Definitions and Standards for Expedited Reporting, 3.1.1 Spontaneous Reports.

  • Spontaneous Reports Non-serious AEs from spontaneous source are sent as separate line-listing within the respective "Periodic Safety Update Report" (see 5.1.3.).

  • Table 106: Spontaneous Reports of Deaths for COCs Containing Ethinyl Estradiol and Dienogest DrugAgeCause and other commentsEE/DNG16Pulmonary embolism – factor V Leiden family historyEE/DNG37Pulmonary embolism – history of varicosities with sclerosing measuresEE/DNG33Pulmonary embolism – BMI = 32.5 kg/m2EE/DNG26Thrombotic thrombocytopenic purpuraEE/DNG17Pulmonary embolismEE/DNG37Pulmonary embolismSource: Summary PSUR (1995-2007) pages 1-13 of 13.

  • Fortier, Spontaneous Reports of Emotional Upset and Health Care Utilization Among Veterans With Posttraumatic Stress Disorder After Re- ceiving a Potentially Upsetting Survey.

  • Licensee shall provide to Oncolytics information of Spontaneous Reports in the Territory in writing, using any mutually agreed format within the timeframes defined in Section 8.3. The reporting form shall include all the information provided by the Spontaneous Source.

Related to Spontaneous Reports

  • 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.

  • Progress Reports The Progress Reports as required by the individual Task Work Orders issued pursuant to this Agreement. Responsible: Responsible or Responsibility means the financial ability, legal capacity, integrity and past performance of Contractor and as such terms have been interpreted relative to public procurements. See NYS Finance Law § 163(1)(c).

  • 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.

  • 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);

  • 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.

  • Progress Report means the report similar in form and content to that attached hereto as Appendix III.

  • Company’s Reports means (i) the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the SEC, including the audited financial statements contained therein; (ii) the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as filed with the SEC, including the unaudited financial statements contained therein, and (iii) the Company’s public reports for the year ended December 31, 2019 and the period ended June 30, 2020, as filed with the FRB as required by regulations of the FRB.

  • 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.

  • REO Status 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.

  • Information Package means the most recent compilation of financial and other data with respect to the Failed Bank, including any amendments or supplements thereto, provided to the Assuming Institution by the Corporation on the web site used by the Corporation to market the Failed Bank to potential acquirers.

  • 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.

  • CREFC® REO Status Report The report in the “REO Status 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.

  • Data Tape Information The information provided by the Originators as of the Cut-off Date to the Depositor or the Purchaser setting forth the following information with respect to each Mortgage Loan: (1) the Mortgagor's name; (2) as to each Mortgage Loan, the Scheduled Principal Balance as of the Cut-off Date; (3) the Mortgage Rate Cap; (4) the Index; (5) a code indicating whether the Mortgaged Property is owner occupied; (6) the type of Mortgaged Property; (7) the first date on which the Scheduled Payment was due on the Mortgage Loan and, if such date is not consistent with the Due Date currently in effect, such Due Date; (8) the "paid through date" based on payments received from the related Mortgagor;

  • 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;

  • Safeguards Monitoring Report means each report prepared and submitted by the Borrower to ADB that describes progress with implementation of and compliance with the EMP and the RP, including any corrective and preventative actions;

  • Electronic Subcontracting Reporting System (eSRS) means the Governmentwide, electronic, web-based system for small business subcontracting program reporting. The eSRS is located at http://www.esrs.gov.

  • 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.

  • 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.

  • Sales Report means a report in substantially the form set forth in Exhibit B “Royalty Report Form”.

  • 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.

  • Insider Report means a statement required to be filed pursuant to Section 16 of the Exchange Act (or any successor provisions), by a person who is a director of the Corporation or who is directly or indirectly the beneficial owner of more than ten percent of the shares of the Corporation.

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

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

  • Receiving report means the data required by the clause at 252.246-7000, Material Inspection and Receiving Report.