Adverse Reaction Reports definition

Adverse Reaction Reports means an adverse event or adverse drug reaction as defined (i) in the ICH E2A document, (ii) in any clinical safety reports, as referenced in 21 C.F.R. 312.32 (as may be amended from time to time), or (iii) any international equivalent definitions used by Regulatory Authorities in the Territory. The definition will be considered updated as these documents are officially amended by the ICH and applicable Regulatory Authorities to ensure compliance with regulatory reporting requirements.
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Adverse Reaction Reports. Adverse Reaction Reports shall have the meaning assigned to it in Section 4.7(i)(ii).
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Adverse Reaction Reports shall have the meaning assigned to such term in Section 6.2.2 hereof.
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Examples of Adverse Reaction Reports in a sentence

  • Detailed records of all adverse events must be kept, must be available to the regulatory authorities upon request, and should be cognisant of guidelines released such as ‘Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports arising from Clinical Trials on Medicinal Products for Human use, CT-3’(2011/C 172/01).

  • In the case of Adverse Reaction Reports within the scope of 21 CFR 314.80(c)(iii), GILEAD shall transmit such Adverse Reaction Reports so that they are received by ROCHE within three (3) business days after receipt by GILEAD, or such other reporting period as may be required by law.

  • ROCHE shall transmit Adverse Reaction Reports to GILEAD on a periodic basis, but no less often than once every three (3) months; provided, however, that ROCHE shall promptly notify GILEAD of any Adverse Reaction Report requiring the alteration of detailing activities by the GILEAD sales force.

  • ALLERGAN shall be solely responsible for all activities in connection with the Regulatory Approvals for Elestat in the Territory, including without limitation communicating and preparing and filing all reports (including, without limitation, Adverse Reaction Reports) with the FDA.

  • The Adverse Reaction Reports (ADRs) occurred most frequently in the following Medra System Organ Classes (SOCs): Skin and subcutaneous tissue disorders (1197), Nervous system disorders (501), Metabolism and nutrition disorders (444), Investigations (420) and General disorders and administration site conditions (403).

  • The Adverse Reaction Reports Analysis Tool is not the first application to employ the use of treemaps, timelines, and statistics panels to convey different aspects of a specified set of data.

  • During the Term of the Agreement, each party shall notify the other of all information coming into its possession concerning side effects, injury, toxicity, pregnancy or sensitivity reaction associated with commercial or clinical uses, studies, investigations or tests with Product, throughout the world, whether or not determined to be attributable to Product ("Adverse Reaction Reports").

  • Comparison of Adverse Reaction Reports for Rivastigmine and Donepezil Using the FDA’s Adverse Event Reporting System.

  • Finally, it is evident that the purpose of the Adverse Reaction Reports Analysis Tool is clear even to first-time users as question 1 of task 1 had the single highest intuitiveness rating of the entire study, at 3.778.

  • Evaluation ofRadiopharmaceutical Adverse Reaction Reports to the British Nuclear Medicine Society from 2007 to 2016Tracia-Gay Kennedy-Dixon, Maxine Gossell-Williams, Margaret Cooper, Moez Trabelsi, and Sobhan Vinjamuri INSTRUMENTATION 2013 Optimization of SPECT Measurement of Myocardial Blood Flow with Corrections for Attenuation, Motion, and Blood Binding Compared with PETR.


More Definitions of Adverse Reaction Reports

Adverse Reaction Reports shall have the meaning provided in Section 6.1 hereof.
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Related to Adverse Reaction Reports

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Exception Report The report of the Trustee referred to in Section 2.02.

  • 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.

  • 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.

  • Evaluation Report means a report on the evaluation of tenders prepared under CSO 12

  • Condition Report means a condition report with respect to a Program Vehicle, signed and dated by the Servicer and a Manufacturer or its agent in accordance with the applicable Manufacturer Program.

  • 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.

  • Material Compliance Matter has the same meaning as the term defined in Rule 38a-1, and includes any compliance matter that involves: (1) a violation of the federal securities laws by Distributor (or its officers, directors, employees, or agents); (2) a violation of Distributor's Rule 38a-1 policies and procedures; or (3) a weakness in the design or implementation of Distributor's Rule 38a-1 policies and procedures.

  • 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.

  • 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.

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Investigative consumer report means a consumer report or portion thereof in which information about a natural person's character, general reputation, personal characteristics, or mode of living is obtained through personal interviews with the person's neighbors, friends, associates, acquaintances, or others who may have knowledge concerning such items of information.

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

  • Project Report means a summary statement of the likely environmental effects of a proposed development referred to in section 58;

  • Transaction Report is that certain report of transactions and schedule of collections in the form attached hereto as Exhibit C.

  • Collection Report means the monthly report prepared by the Primary Servicer setting forth, with respect to each Mortgage Loan and the most recently ended Collection Period prior to the due date of such report, the information described on Exhibit G attached hereto.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Verification Report As defined in Section 4.19.

  • 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.

  • Phase I Environmental Report means a report by an Independent Person who regularly conducts environmental site assessments in accordance with then current standards imposed by institutional commercial mortgage lenders and who has a reasonable amount of experience conducting such assessments.

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

  • Required Reports means, collectively, the Servicing Report required pursuant to Section 6.08(b), the Servicer’s Certificate required pursuant to Section 6.08(c), the financial statements of the Servicer required pursuant to Section 6.08(d), the tax returns of the Borrower and the Servicer required pursuant to Section 6.08(e), the financial statements and valuation reports of each Obligor required pursuant to Section 6.08(f), the annual statements as to compliance required pursuant to Section 6.09, and the annual independent public accountant’s report required pursuant to Section 6.10.

  • 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).

  • Environmental Report The environmental audit report or reports with respect to each Mortgaged Property delivered to the related Mortgage Loan Seller in connection with the origination or acquisition of the related Mortgage Loan.

  • Adverse Environmental Condition shall refer to (i) the existence or the continuation of the existence, of an Environmental Emission (including, without limitation, a sudden or non-sudden accidental or non-accidental Environmental Emission), of, or exposure to, any substance, chemical, material, pollutant, Contaminant, odor or audible noise or other release or emission in, into or onto the environment (including, without limitation, the air, ground, water or any surface) at, in, by, from or related to any Equipment, (ii) the environmental aspect of the transportation, storage, treatment or disposal of materials in connection with the operation of any Equipment or (iii) the violation, or alleged violation of any statutes, ordinances, orders, rules regulations, permits or licenses of, by or from any governmental authority, agency or court relating to environmental matters connected with any Equipment.