Vigilance System Sample Clauses

The Vigilance System clause establishes a framework for monitoring and reporting unethical or illegal activities within an organization. Typically, it requires the implementation of procedures for employees and stakeholders to confidentially report concerns, and may mandate regular training or audits to ensure compliance. This clause is essential for promoting transparency, deterring misconduct, and ensuring that issues are identified and addressed promptly, thereby protecting the organization from legal and reputational risks.
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Vigilance System. Centogene shall maintain and document a vigilance system for Contract DBS ▇▇.▇▇ Kits which is in accordance with Regulatory Approvals, Applicable Laws and Standards. To the extent required by Applicable Laws, Centogene shall be responsible for literature review, maintaining a global safety database, Incident reporting, Incident follow-up reports, preparation and submission of all safety reports towards Regulatory Authorities, as well as deciding upon and conducting any field safety corrective notices/ actions, subject to the terms of this Agreement.
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Vigilance System. Vapotherm has an established Authorized Representative to communicate complaints and vigilance reports that results from the use of the Cartridges. (a) Complaint investigations shall be a shared process between Medica (QA, manufacturing, and engineering) and Vapotherm (QA, Manufacturing, and R&D). (b) All investigation reports shall be issued jointly and in a timely manner to satisfy the requirements for vigilance reporting (when necessary). [* * *] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. (c) When a complaint is determined to be a vigilance reportable event then Vapotherm shall be responsible for administering and reporting to both Medica and the necessary competent authorities any Cartridge related vigilance incidents within [* * *] days or as outlined in the Vapotherm Quality System. (d) Vapotherm shall copy in writing via email or facsimile to Medica Quality Assurance within 24-48 hours on all and any vigilance reporting, including health outcome, relationship between the incidents, and timeliness of reporting the vigilance incident to the Competent Authorities.
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Vigilance System. Medica shall handle any and all international product complaints and vigilance reporting that results from the use of Nephros product. A monthly trending report shall be issued to Nephros Quality Assurance detailing the aforementioned complaints and vigilance incidents and corrective action activities. The following statements outline the responsibilities for the handling and reporting of complaints and vigilance reportable incidents: a) All vigilance reports shall be communicated to Nephros Quality Assurance within 24 to 48 hours of evaluation and confirmation. b) All individual complaints shall be communicated to Nephros for evaluation and confirmation. c) Complaints shall be evaluated for confirmation both by Medica upon receipt and by Nephros following communication from Medica. d) Complaint investigations shall be a shared process between Medica (QA, Manufacturing, and Engineering) and Nephros (QA and R&D). e) All investigation reports shall be issued jointly and in a timely manner to satisfy the requirements for vigilance reporting (when necessary). f) When a complaint is determined to be a vigilance reportable event then Medica shall be responsible for administering and reporting Nephros product related vigilance incidents to the necessary competent authorities within 10 days or as outlined in the Nephros Quality System. g) Any vigilance reportable complaint shall be forwarded to the Nephros Authorized Representative for reporting to the appropriate Competent Authority h) Medica shall copy Nephros Quality Assurance within 24-48 hours on all and any vigilance reporting, including health outcome, relationship between the incidents, and timeliness of reporting the vigilance incident to the Competent Authorities.
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Related to Vigilance System

  • Pharmacovigilance Licensee shall maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. Licensee shall ensure that it will comply with all Applicable Law regarding Licensed Product in the Territory, including, without limitation, those laws and regulations relating to risk management, drug safety and pharmacovigilance. If Licensee becomes aware of any adverse reaction relating to Licenced Product in connection with this Agreement, Licensee shall inform MPP and Pfizer within twenty-four (24) hours of its becoming aware and cooperate with Pfizer in fulfilling Pfizer’s reporting responsibilities under Applicable Law. Licensee will be responsible for fulfilling all pharmacovigilance activities pursuant to the local regulations and requirements for the Licenced Products in the Territory and provide MPP and Pfizer with a report containing information regarding all such activities. Such report shall be provided annually, on February 1 of each year, and otherwise on reasonable request by MPP or Pfizer to both MPP and Pfizer’s pharmacovigilance contact as may be designated by Pfizer from time to time. Licensee shall notify MPP and Pfizer forthwith of the receipt of an enquiry from an Agency in the Territory relating to Licensed Product that concerns any safety issue. If Licensee becomes aware of any action that may be, will be or has been taken by an Agency for a safety reason connected with Licensed Product, it shall immediately, and in any event no later than twenty-four

  • Pharmacovigilance Agreement Subject to the terms of this Agreement, and at a date to be determined by the JDC, Facet and Trubion shall define and finalize the actions the Parties shall employ to protect patients and promote their well-being in a written agreement (hereinafter referred to as the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Collaboration Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDC. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (as the Parties may agree to modify it from time to time) and to cause its Affiliates and permitted sublicensees to comply with such obligations.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.