Special Situation Reports definition

Special Situation Reports means: a) pregnancy reports; b) reports of medication error, abuse, misuse, or overdose; c) lack of effect reports, d) reports of adverse reactions in infants following exposure from breastfeeding; e) reports of adverse reactions associated with product complaints; and f) reports arising from occupational exposure.
Special Situation Reports means: a) pregnancy reports; b) reports of medication error, abuse, misuse, or overdose; c) lack of effect reports, d) reports of adverse reactions in infants following exposure from breastfeeding; e) reports of adverse reactions associated with product complaints; and f) reports arising from occupational exposure. Sperimentatore sia l’Istituto forniranno ragionevole assistenza a Gilead per consentire a Gilead di conformarsi a tutti i requisiti applicabili. Per “Situazioni particolari” si intendono: a) segnalazioni di gravidanza; b) segnalazioni di errore, abuso, uso improprio o sovradosaggio di farmaci; c) segnalazioni di mancanza di efficacia; d) segnalazioni di reazioni avverse in lattanti a seguito di esposizione al latte materno; e) segnalazioni di reazioni avverse associate a reclami relativi a un prodotto; e f) segnalazioni derivanti da esposizione professionale.
Special Situation Reports means: a) pregnancy reports;

Examples of Special Situation Reports in a sentence

  • Institution and Investigator will report all serious adverse events, Special Situation Reports (defined below), and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC.

  • Provider and Investigator will report all serious adverse events, Special Situation Reports (defined below), and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC.

  • For some it was when their pupils did not ask questions when they had doubts, for others it was when they felt they were not motivating their students sufficiently, and for many others it was when their work left much to be desired despite making a considerable effort.

  • HCRN will report all protocol-defined Adverse Events (AEs)/SAEs, AEs of Special Interest (AESIs), Special Situation Reports (including pregnancy reports) and Product Complaints (with or without an AE) originating from the Study for the Product to Genentech within 1 business day of receipt of the SAE Submission Form from a site.

  • The Sponsor-investigator will be responsible for collecting all protocol-defined Adverse Events (AEs)/Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Special Situation Reports (including pregnancy reports) and Product Complaints (with or without an AE) originating from the Study for the Product.

  • UC Davis will be responsible for collecting all protocol-defined Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Special Situation Reports (including pregnancy reports) and Product Complaints (with or without an AE) originating from the Study for the Product.Investigators must report all the above mentioned single case reports adequately to Genentech within the timelines described below.

  • Dr. Stone/ Sponsor will be responsible for collecting all protocol-defined Adverse Events (AEs)/Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Special Situation Reports (including pregnancy reports) and Product Complaints (with or without an AE) originating from the Study for the Product.Investigators must report all the above mentioned single case reports adequately to Genentech within the timelines described below.

  • Sponsor will track all protocol-defined AE Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Special Situation Reports and pregnancy reports originating from the Study for the Product and and Product Complaints (with or without an AE) originatingfrom the Study for the Product.

  • All Serious Adverse Events will be reported to Gilead DSPH within 3 calendar days of knowledge of the event and all Nonserious Adverse Events/ Special Situation Reports will be reported to Gilead DSPH within 5 calendar days of knowledge of the event.

  • Institution and Investigator will report all serious adverse events, Special Situation Reports (defined below), and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH- E2A and the European Union Directive 2001/20/EC.


More Definitions of Special Situation Reports

Special Situation Reports means: a) pregnancy reports; b) reports of medication error, abuse, misuse, or overdose; c) lack of effect reports, d) reports of adverse reactions in infants following exposure from breastfeeding; e) reports of adverse reactions associated with product complaints; and f) reports arising from occupational exposure. 1.8 Bezpečnostní hlášení Instituce a Zkoušející budou hlásit všechny závažné nežádoucí příhody, Hlášení zvláštních situací (definované níže), a/nebo nebo jiné bezpečnostní problémy, které jsou určeny v Protokolu a v souladu s příslušnými zákony, pravidly a vyhláškami, které, kromě jiných, obsahují ICH-E2A a Směrnici Evropské Unie 2001/20/ES. Pro vyloučení pochybností se tímto sjednává, že Zkoušející i Instituce poskytnou přiměřenou pomoc Gilead, aby mu umožnili vyhovět všem příslušným požadavkům. „Hlášení zvláštních situací“ znamenají: a) hlášení těhotenství; b) hlášení chybného podání, zneužití a nesprávného užití léků nebo předávkování léky; c) hlášení nedostatečné účinnosti; d) hlášení nežádoucích účinků u kojenců po expozici při kojení; e) hlášení nežádoucích účinků spojovaných se stížnostmi na přípravek a f) hlášení související s pracovní expozicí.

Related to Special Situation Reports

  • Asset Management is a principle/practice that includes planning processes, approaches, plans, or related documents that support an integrated lifecycle approach to the effective stewardship of infrastructure assets to maximize benefits and effectively manage risk.

  • Asset Management Plan means a strategic document that states how a group of assets are to be managed over a period of time. The plan describes the characteristics and condition of infrastructure assets, the levels of service expected from them, planned actions to ensure the assets are providing the expected level of service, and financing strategies to implement the planned actions. The plan may use any appropriate format, as long as it includes the information and analysis required to be in a plan as described in Ontario’s Building Together: Guide for Asset Management Plans.

  • Individual monitoring means the assessment of:

  • Asset Management Company/UTI AMC/AMC/Investment Manager means the UTI Asset Management Company Limited incorporated under the Companies Act, 1956, (1 of 1956) replaced by The Companies Act, 2013 (No. 18 of 2013) and approved as such by Securities and Exchange Board of India (SEBI) under sub-regulation (2) of Regulation 21 to act as the Investment Manager to the schemes of UTI Mutual Fund;

  • Asset Management Company means an asset Management Company as defined in the Rules and Regulations.

  • Asset Management Company/UTI AMC/AMC/Investment Manager means the UTI Asset Management Company Limited incorporated under the Companies Act, 1956, (1 of 1956) [replaced by The Companies Act, 2013 (No.18 of 2013)] and approved as such by Securities and Exchange Board of India (SEBI) under sub-regulation (2) of Regulation 21 to act as the Investment Manager to the schemes of UTI Mutual Fund.

  • Asset Management Agreement means, as the context requires, any agreement entered into between a Series and an Asset Manager pursuant to which such Asset Manager is appointed as manager of the relevant Series Assets, as amended from time to time.

  • Cross-Over Situation For any Distribution Date and for each Loan Group (after taking into account principal distributions on such Distribution Date) with respect to the Class A and Class B Lower Tier REMIC Interests, a situation in which the Class A and Class B Interests corresponding to any Loan Group are in the aggregate less than 1% of the Subordinated Portion of the Loan Group to which they correspond.

  • S&P CDO Monitor The dynamic, analytical computer model developed by S&P and used to calculate the default frequency in terms of the amount of debt assumed to default as a percentage of the original principal amount of the Collateral Obligations consistent with a specified benchmark rating level based upon certain assumptions (including the applicable S&P Minimum Weighted Average Recovery Rate) and S&P’s proprietary corporate default studies, as may be amended by S&P from time to time upon notice to the Issuer, the Trustee, the Collateral Manager and the Collateral Administrator. Each S&P CDO Monitor will be chosen by the Collateral Manager (with notice to the Collateral Administrator) and associated with either (x) an S&P Minimum Weighted Average Recovery Rate and an S&P Minimum Weighted Average Floating Spread from Section 2 of Schedule 4 or (y) an S&P Minimum Weighted Average Recovery Rate and an S&P Minimum Weighted Average Floating Spread confirmed by S&P, provided that as of any date of determination the Weighted Average S&P Recovery Rate for the Highest Ranking Class equals or exceeds the S&P Minimum Weighted Average Recovery Rate for such Class chosen by the Collateral Manager and the Weighted Average Floating Spread equals or exceeds the S&P Minimum Weighted Average Floating Spread chosen by the Collateral Manager. The model version of the S&P CDO Monitor is available at xxxxx://xxx.xx.xxxxxxxxxxxxxx.xxx.

  • Public Finance Management Act ’ means the Public Finance Management Act, 1999 (Act No. 1 of 1999);

  • Management Group means at any time, the Chairman of the board of directors, the Chief Executive Officer, the President, any Managing Director, Executive Vice President, Senior Vice President or Vice President, any Treasurer and any Secretary of Holdings or other executive officer of Holdings or any Subsidiary of Holdings at such time.

  • Financial Monitoring Report or “FMR” means each report prepared in accordance with Section 4.02 of this Agreement;

  • Appraisal management company means, in connection with valuing properties collateralizing mortgage loans or mortgages incorporated into a securitization, any external third party that oversees a network or panel of more than fifteen certified or licensed appraisers in this state or twenty-five or more nationally within a given year, that is authorized either by a creditor of a consumer credit transaction secured by a consumer's principal dwelling or by an underwriter or other principal in the secondary mortgage markets that engages in appraisal management services.

  • Environmental Management Plan or “EMP” means the environmental management plan for the Project, including any update thereto, incorporated in the IEE;

  • Financial Management Manual means the manual dated June 2009, adopted by the Project Implementing Entity for the purpose of implementing and monitoring the financial management aspects of the Project.

  • LLC means Limited Liability Company.

  • GS shall have the meaning assigned to such term in the preamble to this Agreement.

  • Environmental Management Framework or “EMF” means the policy framework for environmental management, approved by the Project Implementing Entity’s Board of Directors on July 21, 2009, which sets forth the environmental policies and procedures that shall apply to the carrying out of the Project.

  • Individual monitoring devices means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal air sampling devices.

  • Support Partners – means any successful vendor who entered into partnership agreement with CIPC and/or its clients for the provision of support services to a specific solution.

  • QP means a “qualified purchaser” within the meaning of Section 2(a)(51) of the Investment Company Act.

  • Investment Management Agreement means the Investment Management Agreement, dated as of the date hereof, by and between the Investment Manager and the Borrower.

  • Information Resources means any and all computer printouts, online display devices, mass storage media, and all computer-related activities involving any device capable of receiving email, browsing Web sites, or otherwise capable of receiving, storing, managing, or transmitting Data including, but not limited to, mainframes, servers, Network Infrastructure, personal computers, notebook computers, hand-held computers, personal digital assistant (PDA), pagers, distributed processing systems, network attached and computer controlled medical and laboratory equipment (i.e. embedded technology), telecommunication resources, network environments, telephones, fax machines, printers and service bureaus. Additionally, it is the procedures, equipment, facilities, software, and Data that are designed, built, operated, and maintained to create, collect, record, process, store, retrieve, display, and transmit information.

  • Financial Services means any service of a financial nature, including (but not limited to) —

  • Environmental Management System means an environmental management system or plan of management to address all environmental risks and to ensure compliance with all Environmental Laws and licences;

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;