We use cookies on our site to analyze traffic, enhance your experience, and provide you with tailored content.

For more information visit our privacy policy.

Safety Study Sample Clauses

Safety Study. Initial MAA Approval for the Existing Product in the European Union is accompanied by a post approval commitment requiring that an open label safety study in on label patient populations be carried out on the committed timelines with respect to the Existing Product (“Safety Study”), as further specified in Exhibit 7.1.1. Astellas shall be solely responsible for planning and overseeing the performance of the Safety Study and liaising with the regulatory authorities, provided that Astellas shall keep the JDC informed about all study activities and provided that Astellas shall give reasonable consideration to any comments of the JDC. [***].
AutoNDA by SimpleDocs
Safety Study. The Traffic Operations office is responsible for reducing crashes through the implementation of engineering countermeasures. Therefore, the study’s goal is to develop traffic operational strategies to enhance safety, while minimizing impact, if any, on traffic flow. As part of this assignment, the Consultant shall complete the following tasks consistent with the procedures and guidelines outlined in the FDOT MUTS Manual, MUTCD, HSIP and AASHTO: 1. Collect data relevant to the study location, example: a. Crash data b. Hard copies of police reports c. High crash listing d. Aerial photographs e. Field inventory f. Lighting levels (if night time crashes are the object of the study) g. Other relevant data 2. Summarize the latest 3-year crash data by preparing crash summary tables 3. Review hard copies and: a. Prepare collision diagrams b. Ensure that there are no discrepancies between the police reports, the crash data, and the summary tables 4. Identify significant crash patterns 5. Conduct AM and/or PM peak hour field reviews to assess the existing safety and operational conditions 6. Develop engineering countermeasures to reduce number of crashes and/or the severity of the crash patterns identified while attempting to minimize any negative impact on operations. 7. Present findings at pre-Safety Review Committee meeting (pre-SRC) 8. Revise recommendations, if necessary, based on the input from the pre-SRC meeting and conduct a more detailed safety analysis based on the findings from steps 4 and 6. The findings from step 4 and 6 should not limit the reach of this detailed safety analysis. 9. Assess the constructability of the proposed improvements 10. Prepare an existing condition sketch based on the MUTS Manual 11. When impacts on operations are unavoidable, conduct an operational analysis of the existing and proposed conditions. The operational analysis shall be made using the most recent version of a traffic analysis software package approved by the project manager. The Consultant shall choose the software package based on the software’s ability to analyze the situation under consideration. The following software packages are considered as approved for general analysis: a. Signal 2000: Approved for analysis of single/isolated intersections
Safety Study. The BOARD shall conduct an in-depth safety study to increase safety at crosswalks and corners, and update the same as needed.
Safety StudyThe District Safety office is responsible for reducing crashes through the implementation of engineering countermeasures. Therefore, the study's goal is to develop traffic operational strategies to enhance safety, while minimizing impact, if any, on traffic flow. As part of this assignment, the Consultant shall complete the following tasks consistent with the procedures and guidelines outlined in the FDOT MUTS Manual, FDOT Traffic Engineering Manual, MUTCD, HSIP, AASHTO and any other technical publications approved by the FDOT: 1. Collect data relevant to the study location, example: a. Crash data b. Hard copies of police reports c. High crash listing d. Aerial photographs e. Field inventory f. Lighting levels (if nighttime crashes are the object of the study) g. Other relevant data 2. Summarize the latest 3-year crash data or 5-year of crash data as needed by preparing crash summary tables 3. Review hard copies of critical crash types as needed and: a. Prepare collision diagrams b. Ensure that there are no discrepancies between the police reports, the crash data, and the summary tables 4. Identify significant crash patterns 5. Conduct AM and/or PM peak hour field reviews to assess the existing safety and operational conditions 6. Develop engineering countermeasures to reduce number of crashes and/or the severity of the crash patterns identified while attempting to minimize any negative impact on operations. 7. Present findings to the District Safety office. 8. Revise recommendations, if necessary, based on the input from the Department. 9. Assess the constructability of the proposed improvements 10. Prepare an existing condition sketch based on the MUTS Manual 11. When impacts on operations are unavoidable, conduct an operational analysis of the existing and proposed conditions. The operational analysis shall be made using the most recent version of a traffic analysis software package approved by the project
Safety StudyThe Union will have the availability to use other (Canada) Ltd. Branches for a study on safety, health and W.C.B, issues that are a concern in the work place. If will be done in a manner that it will not interfere with the operations of the Branches.

Related to Safety Study

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Safety Program The Contractor shall design a specific safety program for the Work for the site(s). The Contractor shall establish and require all Subcontractors to establish reasonable safety programs. The Contractor shall also submit its standard monthly safety reports to the Owner and Design Professional. No imposition of responsibility on the Contractor for safety under this Contract shall relieve any subcontractor of its responsibility for safety of persons or property on or near the Project Site. The Contractor shall include in his plant he names of the person in charge of Safety.

  • Feasibility Study A feasibility study will identify the potential costs, service quality and other benefits which would result from contracting out the work in question. The cost analysis for the feasibility study shall not include the Employer’s indirect overhead costs for existing salaries or wages and benefits for administrative staff or for rent, equipment, utilities, and materials, except to the extent that such costs are attributable solely to performing the services to be contracted out. Upon completion of the feasibility study, the Employer agrees to furnish the Union with a copy if the feasibility study, the bid from the Apparent Successful Bidder and all pertinent information upon which the Employer based its decision to contract out the work including, but not limited to, the total cost savings the Employer anticipates. The Employer shall not go forward with contracting out the work in question if more than sixty percent (60%) of any projected savings resulting from the contracting out are attributable to lower employee wage and benefit costs.

  • Safety Plan Developer’s safety plan specifically adapted for the Project. Developer's Safety Plan shall comply with all provisions regarding Project safety, including all applicable provisions in these Construction Provisions.

  • The Study 1The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable:

  • Safety Boots Each employee, after 3 months’ continuous service, will be reimbursed (on production of a receipt), the cost of one pair of safety boots (approved by the employer), in each year, to a maximum of $110.00. All protective clothing such as wet weather jackets, safety helmets, welding jackets, welding xxxxxxx, welding gauntlets, rubber boots, etc, (which remain the property of the Company), will be supplied on all occasions deemed necessary.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • Material Safety Data Sheet Seller shall provide to Buyer with each delivery any Material Safety Data Sheet applicable to the work in conformance with and containing such information as required by the Occupational Safety and Health Act of 1970 and regulations promulgated thereunder or its State approved counterpart.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!