Signal Detection Sample Clauses

Signal Detection. Each Party shall promptly review all information concerning safety of the Product that it has obtained from any source, foreign or domestic, including data derived from clinical trials, epidemiologic studies, and commercial marketing experience reports as part of the scientific literature and from unpublished scientific papers. Of the said information concerning the safety of the Product, if a detected signal has impact on the established safety profile of the Product and new significant risk factors are identified, each Party shall expeditiously communicate the information to the other Party and prior to any specific safety measures.
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Signal Detection. The objective of signal detection is to provide early warning or prompt detection of (or the absence of) a communicable disease or other biological hazard event through recognising signals in the data, to enable a timely public health response. Generally temporal and/or spatio-temporal methods are employed with baseline data used to see if there are patterns that are not ‘normal’.
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Signal Detection. Ultragenyx will be responsible for the conduct of surveillance and safety signal detection activity using the Global Safety Database and ad-hoc reports in accordance with Ultragenyx sponsored study procedures and will notify Physician of safety signals that do, or may, affect the safety profile of the Investigational Product, taking into consideration the urgency of the matter and the Applicable Laws. Ultragenyx será responsable de la realización de la actividad de vigilancia y detección de señales de seguridad utilizando la Base de Datos Global de Seguridad y los informes ad-hoc de acuerdo con los procedimientos de los estudios patrocinados por Ultragenyx y notificará al Médico las señales de seguridad que afecten o puedan afectar al perfil de seguridad del Producto en Investigación, teniendo en cuenta la urgencia del asunto y la Legislación Aplicable. Ultragenyx and Physician will promptly inform each other of all adverse event information relating to Investigational Product, including but not limited to, safety issues that any Party becomes aware of or material safety-related regulatory queries from regulatory authorities taking into consideration the urgency of the matter and the Applicable Laws. Ultragenyx may request assistance from Physician to evaluate and investigate such safety information and Physician undertakes to use reasonably diligent efforts to promptly investigate and respond to Ultragenyx’s requests. Ultragenyx y Physician se informarán mutuamente y con prontitud de toda la información de eventos adversos relacionados con el Producto en Investigación, incluyendo, pero sin limitarse a ello, los problemas de seguridad de los que cualquiera de las Partes tenga conocimiento o las consultas reglamentarias relacionadas con la seguridad de las autoridades reguladoras, teniendo en cuenta la urgencia del asunto y las Leyes Aplicables. Ultragenyx podrá solicitar asistencia al Médico para evaluar e investigar dicha información de seguridad y el Médico se compromete a realizar esfuerzos razonablemente diligentes para investigar y responder con prontitud a las solicitudes de Ultragenyx.
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Signal Detection. CMS shall immediately, and within one (1) Business Day, inform Gelesis in writing of any newly identified safety issue or signal, or any circumstance arising for the Product in the Territory where an action by a Party may be required to protect public health.
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Signal Detection. The Parties shall keep each other informed of all material risks (e.g., based on nonclinical, clinical, quality, epidemiological studies or post marketing safety data) which become known to each Party that would be reasonably likely to have an adverse consequence on the benefit-risk assessment regarding the Licensed Product labeling, or may require immediate safety measures. This would include directives from Regulatory Authorities regarding changes in labeling that would restrict Licensed Product use.
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Signal Detection. 4.3.1 Company shall be responsible for identifying new risks of the product and for informing Dexcel immediately any safety concern or any change in risk- benefit balance of the product. Company will inform Dexcel about a validated signal within 10 days of validation. Dexcel will inform Company of any safety concerns identified by Dexcel within 10 calendar days. Dexcel will inform the national Health Authority with this information, if applicable. 4.3.2 Each party shall notify the other party within five (5) business days regarding any Health Authorities actions or enquiries regarding the Product, including, without limitation: a. Restrictions on distribution or recall actions due to safety issues; b. Clinical trial suspension or protocol amendment for safety and/or efficacy reasons; c. Dosage modification for safety reasons; d. Changes in target population or indications for safety reasons; e. Formulation changes for safety reasons; or f. Modification of the investigator brochure and/or core safety data sheet and/or labelling for safety reasons.
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Signal Detection. Principal as holder of the global safety database will be responsible for signal detection activities. Principal shall promptly notify Distributor if it becomes aware of potential safety signals. Both Parties will discuss if there are further actions required with Principal, as the global safety database holder, having the right to make final decisions.
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Related to Signal Detection

  • Intrusion Detection All systems involved in accessing, holding, transporting, and protecting DHCS PHI or PI that are accessible via the Internet must be protected by a comprehensive intrusion detection and prevention solution.

  • Searchability Offering searchability capabilities on the Directory Services is optional but if offered by the Registry Operator it shall comply with the specification described in this section. 1.10.1 Registry Operator will offer searchability on the web-­‐based Directory Service. 1.10.2 Registry Operator will offer partial match capabilities, at least, on the following fields: domain name, contacts and registrant’s name, and contact and registrant’s postal address, including all the sub-­‐fields described in EPP (e.g., street, city, state or province, etc.). 1.10.3 Registry Operator will offer exact-­‐match capabilities, at least, on the following fields: registrar id, name server name, and name server’s IP address (only applies to IP addresses stored by the registry, i.e., glue records). 1.10.4 Registry Operator will offer Boolean search capabilities supporting, at least, the following logical operators to join a set of search criteria: AND, OR, NOT. 1.10.5 Search results will include domain names matching the search criteria. 1.10.6 Registry Operator will: 1) implement appropriate measures to avoid abuse of this feature (e.g., permitting access only to legitimate authorized users); and 2) ensure the feature is in compliance with any applicable privacy laws or policies.

  • Signaling Each Party will provide the other Party with access to its databases and associated signaling necessary for the routing and completion of the other Party’s traffic in accordance with the provisions contained in the Unbundled Network Element Attachment or applicable access tariff.

  • Prevention IP shall take all appropriate measures to prevent sexual exploitation and abuse, and child safeguarding violations, by its employees, personnel or subcontractors. IP shall, inter alia, ensure that its employees, personnel or subcontractors shall have undertaken and successfully completed appropriate training with regard to the prevention of sexual exploitation and abuse, and training on safeguarding children. Such training shall include but not be limited to: reference to definitions of sexual exploitation and sexual abuse, and child safeguarding violations; a clear and unambiguous statement that any form of sexual exploitation and abuse, and any conduct that undermines the safeguarding of children, is prohibited; the requirement that any allegations of sexual exploitation and abuse, or child safeguarding violations be promptly reported as provided for in Article 14.4; and the requirement that alleged victims of sexual exploitation and abuse or child safeguarding violations, be promptly informed of and referred to available professional assistance, upon her or his consent.

  • Erosion Prevention and Control Purchaser’s Operations shall be conducted reasonably to minimize soil erosion. Equipment shall not be operated when ground conditions are such that excessive damage will result. Purchaser shall adjust the kinds and intensity of erosion control work done to ground and weather condi- tions and the need for controlling runoff. Erosion control work shall be kept current immediately preceding ex- pected seasonal periods of precipitation or runoff.

  • Violence in the Workplace (a) The parties agree that violence shall be defined as any incident in which an employee is abused, threatened or assaulted while performing his or her work. The parties agree it includes the application of force, threats with or without weapons and severe verbal abuse. The parties agree that such incidents will not be condoned. Any employee who believes he/she has been subjected to such incident shall report this to a supervisor who will make every reasonable effort to rectify the situation. For purposes of sub-article (a) only, employees as referred to herein shall mean all employees of the Employer notwithstanding Article 2.12. (b) The Employer agrees to develop formalized policies and procedures in consultation with the Joint Health and Safety Committee to deal with workplace violence. The policy will address the prevention of violence and the management of violent situations and support to employees who have faced workplace violence. These policies and procedures shall be communicated to all employees. The local parties will consider appropriate measures and procedures in consultation with the Joint Health and Safety Committee to address violence in the workplace, which may include, among other measures and procedures: i) Alert employees about a person with a known history of aggressive and responsive behaviours and their known triggers by means of: A) electronic and/or other appropriate flagging systems, B) direct verbal communication / alerts (i.e. shift reports), ii) Communicate and provide appropriate training and education, iii) Reporting all incidents of workplace violence, iv) Long-term care home wide violence risk assessments. (c) The Employer will report all incidents of violence as defined herein to the Joint Health and Safety Committee for review. (d) The Employer agrees to provide training and information on the prevention of violence to all employees who come into contact with potentially aggressive persons. This training will be done during a new employee’s orientation and updated as required. (e) Subject to appropriate legislation, and with the employee’s consent, the Employer will inform the Union within three (3) days of any employee who has been subjected to violence while performing his/her work. Such information shall be submitted in writing to the Union as soon as practicable.

  • Signaling Link Transport 9.2.1 Signaling Link Transport is a set of two or four dedicated 56 kbps transmission paths between Global Connection-designated Signaling Points of Interconnection that provide appropriate physical diversity.

  • Accident Prevention Health and Safety Committee (a) The Employer and the Union agree that they mutually desire to maintain standards of safety and health in the workplace in order to prevent accidents, injury and illness. (b) Recognizing its responsibilities under the applicable legislation, the Employer agrees to accept as a member of its Accident Prevention – Health & Safety Committee at least three (3) representatives, one from each base, selected or appointed by the Union from amongst bargaining unit employees. At any time where a vote is required, an equal number of representatives from each side shall be entitled to vote. (c) Such Committee shall identify potential dangers and hazards, institute means of improving health and safety programs and recommend actions to be taken to improve conditions related to safety and health. (d) The Employee agrees to co-operate reasonably in providing necessary information to enable the Committee to fulfill its functions. (e) Meetings shall be held quarterly or more frequently at the call of the Chair if required. The Committee shall maintain minutes of all meetings and make the same available for review. (f) Any representative appointed or select in accordance with (b) hereof shall serve a term of one (1) calendar year from the date of appointment which may be renewed for further periods of one (1) year. The Union will encourage its representative(s) to serve at least one (1) year. Time off for such representative(s) to attend meetings of the Accident Prevention – Health & Safety Committee in accordance with the foregoing shall be granted and time so spent attending such meetings shall be deemed to be work time for which the representative(s) shall be paid by the Employer at his regular or premium rate as may be applicable. (g) The Union agrees to endeavour to obtain the full co-operation of its membership in the observation of all safety rules and practices. (h) Pregnant employees may request to be transferred from their current duties if, in the professional opinion of the employee’s physician, the pregnancy may be at risk. If such a transfer is not feasible, the pregnant employee, if she so requests, will be granted an unpaid leave of absence before commencement of the maternity leave referred to in Article 16.04

  • Smoke Detectors At Owner's expense, smoke detectors will be installed on the Property in working condition in accordance with the law prior to the tenant's occupancy. During the occupancy, it shall be the tenant's responsibility to maintain all smoke detectors. Owner will replace smoke detector equipment as needed.

  • Contamination The presence in, on or under land, air or water of a substance (whether a solid, liquid, gas, odour, heat, sound, vibration or radiation) at a concentration above the concentration at which the substance is normally present in, on or under land, air or water in the same locality, that presents a risk of Environmental Harm, including harm to human health or any other aspect of the Environment, or could otherwise give rise to a risk of non-compliance with any Statutory Requirement for the protection of the Environment.

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