Safety Evaluation Clause Samples

Safety Evaluation. 14.1 Celestial and BWTP shall notify GSK and shall supply to GSK any information, together with any supporting documentation, that it considers indicates a safety issue in relation to the Medicinal Product no later than twenty-four (24) hours from the identification by it of the safety issue. 14.2 Celestial and BWTP shall supply GSK with all relevant information requested by GSK which that Party is entitled to disclose to GSK, including where applicable any supporting documentation and ad hoc support through verbal consultation, to equip GSK with the information GSK requires to comply with its internal safety review processes for products under investigation in GSK-sponsored Clinical Trials.
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Safety Evaluation. Each Party shall provide the following information with respect to its Compound to be used in a Combined Therapy Study: (i) the latest investigator’s brochure and annual updates (with such updates to be provided within five (5) Business Days after being finalized), (ii) list of ongoing clinical studies, (iii) Aggregate Safety Information that emerge from all other clinical trials of the Party’s Compound within five (5) Business Days after general distribution within such Party, (iv) prompt notice of any material safety interactions with any Regulatory Authority and the substance thereof regarding any clinical trials of the Party’s Compound during the term of this Agreement; (v) a summary of all new clinically relevant toxicology study data on the Party’s Compound within five (5) Business Days after generation of such summary within such Party, (vi) safety analyses for the Combined Therapy Study in accordance with the applicable Statistical Analysis Plan, and (vii) such other safety data as set forth in the Pharmacovigilance Agreement. Except as permitted under Section 8.3(g) and Section 8.4, each Party shall use any such information provided by the other Party pursuant to this Section 2.1(g) solely to evaluate the safety of the Combined Therapy and the Compounds for use in the Combined Therapy Study.
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Safety Evaluation. In accordance with design procedure 331-86 and KAA-709 for safety screening / evaluation / justification is required. Where there is a possible interface with / impact on safety related equipment, the Contractor’s design complies with the applicable design codes as described in the KNPS Safety Analysis Report (ASME, IEEE etc). The Contractor’s design is such that it does not introduce any additional risk to the safety and / or operation of the plant and / or its people and / or the environment. Activity description Project Manager Contractor Requirements Planning Additional notes Authorisation of individuals in accordance with KTA-001. X All safety screenings, evaluations and justifications are performed by authorised individuals in accordance with KTA-001 Error! Reference source not found.. After tender phase Compilation of an Scheme Design document / Installation Design document and independent reviews X Process in accordance with KAA-709 Error! Reference source not found.. In accordance with Accepted Programme Although not obligatory, it is encouraged that the compiler of the design may not be the compiler of the Safety Evaluation documentation. Probabilistic Safety Assessments (PSA) evaluation. X The Employer performs the PSA. The Contractor to supply all relevant input information when requested to furnish information Incorporate PSA results into safety evaluation and confirm applicability of PSA to detailed design X The Contractor notifies the Project Manager of any discrepancies in the PSA study. The Contractor corrects any safety concerns highlighted by the Safety Evaluation / Safety Justification / PSA in its design. In accordance with Accepted Programme Presentation of safety evaluations, justifications and cases to Koeberg Operations Review Committee (KORC) for approval. X The Project Manager arranges with KORC for an opportunity to present information at KORC. Both the Project Manager and the Contractor technical representatives attend the meeting. The Project Manager or technical delegate performs the presentation. In accordance with Accepted Programme Regular meetings are scheduled every Monday but arrangement of special KORC meetings is possible for urgent issues. Approval of safety evaluation documents. X Project Manager acceptance is subject to the requirements of the safety evaluation process being met. In accordance with Accepted Programme Employer’s KORC Chairman approves the documents. Originals in Scheme Design and copies to TD & RM, ...
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Safety Evaluation. Using the ODOT-calibrated crash prediction models, Kittelson will develop a safety evaluation of the recommended concept for the Greenwood West corridor, and summarize the findings of this evaluation in the Operations Analysis memorandum, above.
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Safety Evaluation. Per NFAS 15.304(d), solicitations utilizing source selection procedures for procurements within the 50 United States, the District of Columbia, and outlying areas shall contain a standard “Safety” technical evaluation factor. This factor shall be included as a stand-alone evaluation factor and not as a sub-factor or an element of the Past Performance evaluation factor. This action will result in the selection of contractors that have consistently demonstrated a commitment to safety and the ability to properly manage and implement safety procedures for themselves and all tiers of subcontractors under their purview.
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Safety Evaluation. All safety data will be included in the subject data listings. Analyses and summary tables will be based upon the safety population. All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) (current version at the time of database lock), and will be classified by MedDRA preferred term and system organ class. AE listings will be presented by subject, system organ class and preferred term. Incidence of all reported AEs/treatment emergent AEs, AESIs, and SAEs will be tabulated by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)) and overall. In addition, summary tables will be presented by maximum intensity, drug relationship and AEs associated with premature withdrawal of IMP. A treatment emergent AE is defined as any AE that occurs during the active phase of the study if: • It was not present prior to receiving the first dose of IMP; or • It was present prior to receiving the first dose of IMP but the intensity increased at any point in the study following the first dose of IMP. Concomitant medication will be coded by using World Health Organisation Drug Dictionary (WHODRUG; current version at the time of database lock) and will be summarised by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)) and overall, with the number and percentage of subjects receiving concomitant medication by drug class and preferred drug name. Summary statistics (mean, median, standard deviation, standard error mean, and range as appropriate) by treatment group and overall will be presented for ▇▇▇▇▇ ▇▇▇▇▇, laboratory safety tests, laboratory urinalysis/microscopy etc. at each assessment with change from Baseline. For laboratory safety data, abnormal values will be flagged in the data listings and a list of clinically significant abnormal values will be presented. Shift tables from Baseline of the number and percentage of subjects with low, normal or high values and normal or abnormal examinations will be presented by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)).
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Related to Safety Evaluation

  • JOC EVALUATION If any materials being utilized for a project cannot be found in the RS Means Price Book, this question is what is the markup percentage on those materials? When answering this question please insert the number that represents your percentage of proposed markup. Example: if you are proposing a 30 percent markup, please insert the number "30". Remember that this is a ceiling markup. You may markup a lesser percentage to the TIPS Member customer when pricing the project, but not a greater percentage. EXAMPLE: You need special materials that are not in the RS Means Unit Price Book for a project. You would buy the materials and ▇▇▇▇ them up to the TIPS Member customer by the percentage you propose in this question. If the materials cost you, the contractor, $100 and you proposed a markup on this question for the material of 30 percent, then you would charge the TIPS Member customer $130 for the materials. TIPS/ESC Region 8 is required by Texas Government Code § 791 to be compensated for its work and thus, failure to agree shall render your response void and it will not be considered. Vendor agrees to remit to TIPS the required administration fee or, if resellers are named, guarantee the fee remittance by or for the reseller named by the vendor?

  • Job Evaluation The work of the provincial job evaluation steering committee (the JE Committee) will continue during the term of this Framework Agreement. The objectives of the JE Committee are as follows: • Review the results of the phase one and phase two pilots and outcomes of the committee work. Address any anomalies identified with the JE tool, process, or benchmarks. • Rate the provincial benchmarks and create a job hierarchy for the provincial benchmarks. • Gather data from all school districts and match existing job descriptions to the provincial benchmarks. • Identify the job hierarchy for local job descriptions for all school districts. • Compare the local job hierarchy to the benchmark-matched hierarchy. • Develop a methodology to convert points to pay bands - The confirmed method must be supported by current compensation best practices. • Identify training requirements to support implementation of the JE plan and develop training resources as required. Once the objectives outlined above are completed, the JE Committee will mutually determine whether a local, regional or provincial approach to the steps outlined above is appropriate. It is recognized that the work of the committee is technical, complicated, lengthy and onerous. To accomplish the objectives, the parties agree that existing JE funds can be accessed by the JE committee to engage consultant(s) to complete this work. It is further recognized that this process does not impact the established management right of employers to determine local job requirements and job descriptions nor does this process alter any existing collective agreement rights or established practices. When the JE plan is ready to be implemented, and if an amendment to an existing collective agreement is required, the JE Committee will work with the local School District and Local Union to make recommendations for implementation. Any recommendations will also be provided to the Provincial Labour Management Committee (PLMC). As mutually agreed by the provincial parties and the JE Committee, the disbursement of available JE funds shall be retroactive to January 2, 2020. The committee will utilize available funds to provide 50% of the wage differential for the position falling the furthest below the wage rate established by the provincial JE process and will continue this process until all JE fund monies at the time have been disbursed. The committee will follow compensation best practices to avoid problems such as inversion. The committee will report out to the provincial parties regularly during the term of the Framework Agreement. Should any concerns arise during the work of the committee they will be referred to the PLMC. Create a maintenance program to support ongoing implementation of the JE plan at a local, regional or provincial level. The maintenance program will include a process for addressing the wage rates of incumbents in positions which are impacted by implementation of the JE plan. The provincial parties confirm that $4,419,859 of ongoing annual funds will be used to implement the Job Evaluation Plan. Effective July 1, 2022, there will be a one-time pause of the annual $4,419,859 JE funding. This amount has been allocated to the local table bargaining money. The annual funding will recommence July 1, 2023.

  • PROGRESS EVALUATION Engineer shall, from time to time during the progress of the Engineering Services, confer with County at County’s election. Engineer shall prepare and present such information as may be pertinent and necessary, or as may be reasonably requested by County, in order for County to evaluate features of the Engineering Services. At the request of County or Engineer, conferences shall be provided at Engineer's office, the offices of County, or at other locations designated by County. When requested by County, such conferences shall also include evaluation of the Engineering Services. County may, from time to time, require Engineer to appear and provide information to the Williamson County Commissioners Court. Should County determine that the progress in Engineering Services does not satisfy an applicable Work Authorization or any Supplemental Work Authorization related thereto, then County shall review same with Engineer to determine corrective action required. Engineer shall promptly advise County in writing of events which have or may have a significant impact upon the progress of the Engineering Services, including but not limited to the following: A. Problems, delays, adverse conditions which may materially affect the ability to meet the objectives of an applicable Work Authorization or any Supplemental Work Authorization related thereto, or preclude the attainment of Project Engineering Services units by established time periods; and such disclosure shall be accompanied by statement of actions taken or contemplated, and County assistance needed to resolve the situation, if any; and B. Favorable developments or events which enable meeting goals sooner than anticipated in relation to an applicable Work Authorization’s or any Supplemental Work Authorization related thereto.

  • TECHNICAL EVALUATION (a) Detailed technical evaluation shall be carried out by Purchase Committee pursuant to conditions in the tender document to determine the substantial responsiveness of each tender. For this clause, the substantially responsive bid is one that conforms to all the eligibility and terms and condition of the tender without any material deviation. The Institute’s determination of bid’s responsiveness is to be based on the contents of the bid itself without recourse to extrinsic evidence. The Institute shall evaluate the technical bids also to determine whether they are complete, whether required sureties have been furnished, whether the documents have been properly signed and whether the bids are in order. (b) The technical evaluation committee may call the responsive bidders for discussion or presentation to facilitate and assess their understanding of the scope of work and its execution. However, the committee shall have sole discretion to call for discussion / presentation. (c) Financial bids of only those bidders who qualify the technical criteria will be opened provided all other requirements are fulfilled. (d) AIIMS Jodhpur shall have right to accept or reject any or all tenders without assigning any reasons thereof.

  • Final Evaluation IC must submit a final report and a project evaluation to the Arts Commission within thirty (30) days after the completion of the Services. Any and all unexpended funds from IC must be returned to City no later than sixty (60) days after the completion of the Services.