Risk minimization measures Sample Clauses

Risk minimization measures. In view of the expected benefits the above listed risks are considered to be manageable in this patient population, if adequate minimization measures are put in place. An overview of specific measures to minimize the subject’s risk is provided below: • Study designed with HLH experts forming the SSC • Patients are hospitalized in specialized centers for the treatment of HLH, and therefore with all necessary emergency assistance equipment • Inclusion/exclusion criteria: patients with malformations or severely altered functions (either due to the disease stage or to a concomitant disease), as well as patients with evidence of patent or latent TB infections or active mycobacteria, Shigella, Salmonella, Campylobacter or Leishmania infections, will not be included in the study (for details see Section 4.1) • Infusion Related Reaction (IRR) monitoring: patients will be very closely monitored during the study drug infusions and for 24 hours following them to immediately identify if the subject is experiencing any IRRs. Each of the specialized centers will have physicians adequately trained in IRR management (please see NI-0501-04 Study Specific Risk Management Plan for further details). • Recommendations on prophylaxis for Pneumocystis jiroveci, fungal infections, Herpes Zoster virus for all patients and Tuberculosis for a defined subpopulation (see section 6.2) in the protocol to avoid occurrence of these infections • Close monitoring of potential infections through careful physical examination, laboratory parameters, active search for EBV, CMV, Adenoviruses, detection of tuberculosis • Study safety surveillance by a Data Monitoring Committee The Development Risk Management Plan addresses risks, identify signals for early detection of safety concerns and propose mitigating actions. It will be part of the study documentation shared with Investigators and any relevant third party involved in the study. Stopping rules have been also developed to ensure individual patient safety and determine whether the study should be put on hold or terminated prematurely.
Sample 1
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Related to Risk minimization measures

  • Mitigation Measures Company shall take commercially reasonable measures (except measures causing it to incur out-of-pocket expenses which BNYM does not agree in advance to reimburse) to mitigate losses or potential losses to BNYM, including taking verification, validation and reconciliation measures that are commercially reasonable or standard practice in the Company’s business.

  • Taxation Measures 1. Except as provided in this Article nothing in this Agreement shall apply to taxation measures. 2. Nothing in this Agreement shall affect the rights and obligations of the Parties under any tax convention. In the event of any inconsistency between the provision of this Agreement and any such convention, the provisions of that convention shall apply to the extent of the inconsistency. 3. Without prejudice to the application of paragraph 2, the disciplines referred to hereinafter shall apply to taxation measures: (a) Article 7 (National Treatment) of Chapter 2 (National Treatment and Market Access for Goods) and such other provisions of this Agreement as are necessary to give effect to that Article to the same extent as does Article III of the GATT 1994; and (b) Article 106 (National Treatment) of Chapter 8 (Trade in Services), subject to the exceptions provided for in Article XIV letters (d) and (e) of the GATS, which are hereby incorporated. 4. The provisions of Article 133 (Expropriation) and Annex 9 (Expropriation) of this Chapter shall apply to taxation measures alleged to be expropriatory. 5. The provisions of Article 139 (Investor-State Dispute Settlement) apply with respect to paragraph 4 of this Article. 6. If an investor invokes Article 133 (Expropriation) and Annex 9 (Expropriation) of this Chapter as the basis of a claim to arbitration according to Article 139 (Investor-State Dispute Settlement), the following procedure shall apply: The investor must first refer to the competent tax authorities described in subparagraph 7(c), at the time that it gives written notice of intent under Article 139 (Investor-State Dispute Settlement), the issue of whether the tax measure concerned involves an expropriation. In case of such referral, the competent tax authorities shall consult. Only if, within 6 months of the referral, they do not reach an agreement that the measure does not involve an expropriation, or in case the competent tax authorities of the Parties fail to consult with each other, the investor may submit its claim to arbitration under Article 139 (Investor-State Dispute Settlement). 7. For purposes of this Article: (a) taxation measures do not include: (i) a customs duty; or (ii) the measures listed in exceptions (b) and (c) of the definition of customs duty; (b) tax convention means a convention, or other international arrangement on taxation, to avoid double taxation; and (c) competent tax authorities means: (i) for China, the State Administration of Taxation; and (ii) for Peru, the Ministry of Economy and Finance, or its successor.

  • Safety Measures Awarded vendor shall take all reasonable precautions for the safety of employees on the worksite, and shall erect and properly maintain all necessary safeguards for protection of workers and the public. Awarded vendor shall post warning signs against all hazards created by the operation and work in progress. Proper precautions shall be taken pursuant to state law and standard practices to protect workers, general public and existing structures from injury or damage.

  • Bilateral Safeguard Measures 1. Where, as a result of the reduction or elimination of a customs duty under this Agreement, any product originating in a Party is being imported into the territory of another Party in such increased quantities, in absolute terms or relative to domestic production, and under such conditions as to constitute a substantial cause of serious injury or threat thereof to the domestic industry of like or directly competitive products in the territory of the importing Party, the importing Party may take bilateral safeguard measures to the minimum extent necessary to remedy or prevent the injury, subject to the provisions of paragraphs 2 to 10.

  • Interim Measures 6.1 The Parties acknowledge that the British Columbia Claims Task Force made the following recommendation concerning interim measures:

  • Safeguard Measures 1. The Parties note the multilateral negotiations pursuant to Article X of GATS on the question of emergency safeguard measures based on the principle of non- discrimination. Upon the conclusion of such multilateral negotiations, the Parties shall conduct a review for the purpose of discussing appropriate amendments to this Agreement so as to incorporate the results of such multilateral negotiations.

  • Emergency Measures Additional measures and/or other special requirements necessary during periods of critical fire-weather conditions shall be included in the fire prevention and presuppression plan.

  • Corrective Measures If the Participating Generator fails to meet or maintain the requirements set forth in this Agreement and/or the CAISO Tariff, the CAISO shall be permitted to take any of the measures, contained or referenced in the CAISO Tariff, which the CAISO deems to be necessary to correct the situation.

  • Protective Measures We have implemented and will maintain appropriate technical and organisational measures in relation to the Services taking into account the state of the art, the costs of implementation, and the nature, scope, context and purposes of Processing, as well as the likelihood and severity of risk to the rights and freedoms of data subjects. This includes measures relating to the physical security of Our facilities used to deliver them, measures to control access rights to Our assets and relevant networks, and processes for testing these measures. In accordance with Our obligations under applicable law, We may undertake digital forensic investigations in relation to the use of the Services and Subscriptions. You are responsible for using, and ensuring that your Users use, the controls and advice provided by the Services correctly and consistently.

  • General Measures (a) Evidence of family violence may be required and can be in the form an agreed document issued by the Police Service, a Court, a registered health practitioner, a Family Violence Support Service, district nurse, maternal and health care nurse or Lawyer. A signed statutory declaration can also be offered as evidence.

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