Safety Follow up Sample Clauses

Safety Follow up. A safety follow-up visit will occur 30 days (+14 days) after last dose of study drug. In some cases, nonserious AE observations may continue beyond the safety visit. All ocular AEs will be followed until resolution, stabilization, or return to baseline. In these instances, additional information may be requested by ImmunoGen to adequately categorize the nature of the toxicity. All serious adverse events will be followed until they resolve, stabilize or return to baseline, regardless of time from last dose or last visit.
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Safety Follow up. As mentioned in previous sections, safety rules apply to each sub-component; these rules may differ following the laboratory where the equipment is installed, adding complexity to the activity. In parallel with the design and manufacture, it is essential to look at the systems' safety and perform various risk analyses to grant the compliance of the systems with applicable rules. Identifying the owner of every component will be required to facilitate the discussion about compliance with Safety Rules. Safety regulations must be followed as the anti-cryostat changes the boundary of the existing cryostats. Required documentation and certification for pressure vessels may differ between the two laboratories (UPPSALA following European safety standards and CERN following internal safety rules that are inspired (but not identical) to E.U. regulations. The pressurized anti-cryostat will have to follow the safety rules for pressure vessels and be in electrical compliance. As this equipment is expected to be used at CERN (SM18), the equipment has to respect the CERN safety Rules (e.g., case GSI-M-4 and may require the application of the PED Directive 2014/68/E.U.). Similarly, the motorized shaft and the rotating coil should follow the machinery directive 2006/42/E.C.: it is required that both laboratories inquire about the applicable rules, as specified early in this document. The anti-cryostat lifting tool has to be C.E. certified as lifting equipment. Due to the complexity of the regulatory framework for this project, it is recommended to appoint reference persons for safety at CERN and at FREIA in order to facilitate exchanges about safety all along the project.
Safety Follow up. As mentioned in previous sections, safety rules apply to each sub-component; these rules may differ following the laboratory where the equipment is installed, adding complexity to the activity. In parallel with the design and manufacture, it is essential to look at the systems' safety and perform various risk analyses to grant the compliance of the systems with applicable rules. Identifying the owner of every component will be required to facilitate the discussion about compliance with Safety Rules. Safety regulations must be followed as the anti-cryostat changes the boundary of the existing cryostats. Required documentation and certification for pressure vessels may differ between the two laboratories (UPPSALA following European safety standards and CERN following internal safety rules that are inspired (but not identical) to E.U. regulations. The pressurized anti-cryostat will have to follow the safety rules for pressure vessels and be in electrical compliance. As this equipment is expected to be used at CERN (SM18), the equipment has to respect the CERN safety Rules (e.g., case GSI-M-4 and may require the application of the PED Directive 2014/68/E.U.). Similarly, the motorized shaft and the rotating coil should follow the machinery directive 2006/42/E.C.: it is required that both laboratories inquire about the applicable rules, as specified early in this document. The anti-cryostat lifting tool has to be C.E. certified as lifting equipment. Due to the complexity of the regulatory framework for this project, it is recommended to appoint reference persons for safety at CERN and at FREIA in order to facilitate exchanges about safety all along the project. Work-package 6: handling tools Documentation Handling, Quality Control, and Quality Assurance All the documentation shall be stored in EDMS. The collaborators shall plan, establish, implement, and adhere to a documented quality assurance program that fulfills all the requirements described in this technical specification and shall be submitted in electronic format: Drawings in CATIA® or AUTOCAD® Text documents in Microsoft Word® and/or PDF format Cost breakdowns and equipment list in Microsoft Excel® format Schedule in Microsoft Project® format Tests to be carried out List of tests (TBD): Assurance of the correct functioning of all operation and safety aspects. Acceptance testing before shipment by checking the static and dynamic behavior with laser tracker systems. Leak test for the anti-cryostat Pressur...

Related to Safety Follow up

  • Definitions As used in this Agreement, the following terms shall have the following meanings:

  • Entire Agreement This DPA and the Service Agreement constitute the entire agreement of the Parties relating to the subject matter hereof and supersedes all prior communications, representations, or agreements, oral or written, by the Parties relating thereto. This DPA may be amended and the observance of any provision of this DPA may be waived (either generally or in any particular instance and either retroactively or prospectively) only with the signed written consent of both Parties. Neither failure nor delay on the part of any Party in exercising any right, power, or privilege hereunder shall operate as a waiver of such right, nor shall any single or partial exercise of any such right, power, or privilege preclude any further exercise thereof or the exercise of any other right, power, or privilege.

  • IN WITNESS WHEREOF the parties hereto have executed this Agreement as of the day and year first above written.

  • Severability Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction.

  • WHEREAS the Company desires the Warrant Agent to act on behalf of the Company, and the Warrant Agent is willing to so act, in connection with the issuance, registration, transfer, exchange, redemption and exercise of the Warrants; and

  • NOW, THEREFORE the parties hereto agree as follows:

  • Termination This Agreement may be terminated at any time prior to the Closing:

  • Insurance The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are prudent and customary in the businesses in which the Company and the Subsidiaries are engaged, including, but not limited to, directors and officers insurance coverage. Neither the Company nor any Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost.

  • Term The term of this Agreement will be ten (10) years from the Effective Date (as such term may be extended pursuant to Section 4.2, the “Term”).

  • Notices Any notice, request or other document required or permitted to be given or delivered to the Holder by the Company shall be delivered in accordance with the notice provisions of the Purchase Agreement.

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