Signal Detection Sample Clauses
The Signal Detection clause establishes procedures and responsibilities for identifying and responding to specific signals or indicators, often related to safety, compliance, or operational performance. In practice, this clause may require parties to monitor for certain warning signs, such as equipment malfunctions, security breaches, or regulatory non-compliance, and to promptly report or act upon these signals according to agreed protocols. Its core function is to ensure timely awareness and response to potential issues, thereby minimizing risks and enhancing the effectiveness of risk management within the agreement.
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epidemiologic studies, and commercial marketing experience reports as part of the scientific literature and from unpublished scientific papers.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.
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’.
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.
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.
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.
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.
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.