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.
Sample 1Sample 2Sample 3
Adverse Reaction Reports shall have the meaning assigned to such term in Section 6.2.2 hereof.
Sample 1Sample 2
Adverse Reaction Reports. Adverse Reaction Reports shall have the meaning assigned to it in Section 4.7(i)(ii).
Sample 1Sample 2

Examples of Adverse Reaction Reports in a sentence

  • 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.

  • 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").

  • Each Party shall transmit such Adverse Reaction Reports so that they are received by the other Party within 30 days after receipt by the transmitting Party, or such other reporting period as may be required by law.

  • Sagent shall notify Anesiva of any complaints and/or Adverse Reaction Reports it receives within [*] as required per 21 CFR 314.80(c)(iii).

  • Anesiva shall notify Sagent within [*] of confirmation of such Adverse Reaction Reports requiring the alteration of the manner in which Sagent performs its services.

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

  • In the case of Adverse Reaction reports within the scope of 21 CFR 314.80(c)(iii), PRAECIS shall transmit such Adverse Reaction Reports relating to Product to ROCHE and XXXXX-Xxxxxx so that they are received by both ROCHE and XXXXX-Xxxxxx within two (2) calendar days after receipt by PRAECIS, or such other reporting period as may be required by law, and ROCHE shall notify PRAECIS of any Adverse Reaction Report relating to Product within two (2) calendar days after receipt thereof by ROCHE.

  • If KPI receives any Adverse Reaction Reports relating to the Product, KPI shall notify CIBA thereof within twenty-four (24) hours via telephone and shall follow-up with a written notification within forty-eight (48) hours after receiving such report.


More Definitions of Adverse Reaction Reports

Adverse Reaction Reports shall have the meaning set forth in Section 7.6(b).
Sample 1

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 As defined in the Custodial Agreement.

  • 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.

  • 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 Group III Vehicle, signed and dated by a Lessee or a Franchisee and any Manufacturer or its agent in accordance with the applicable Vehicle Disposition 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.

  • Home inspection report means a written report that is

  • 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.

  • 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.

  • 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 Collectively, the Monthly Report, the Servicer’s Certificate required pursuant to Section 6.10(c), the financial statements of the Servicer required pursuant to Section 6.10(d), the annual statements as to compliance required pursuant to Section 6.11, and the annual independent public accountant’s report required pursuant to Section 6.12.

  • 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.