Ethics Committee / Regulatory Submissions Sample Clauses

Ethics Committee / Regulatory Submissions. The regulatory management of global clinical trials is a complex undertaking due to the large number of countries involved, and hence successful management is key to rapid project start-up in multiple countries. The following paragraphs outline the ways in which MDS Pharma Services operates to ensure efficient compliance with the regulatory requirements of each country (Only submissions in Ireland and Sweden will be managed by MDS Pharma Services. MDS Pharma Services will also support Gentium for the submissions in France and especially in UK). GENTIUM - VOD - Defibrotide Study - Proposal no. AA2618420 - Version 8
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Related to Ethics Committee / Regulatory Submissions

  • Audit Committee Review Prior to the earlier of the consummation of an initial Business Combination and the Liquidation, the Company’s audit committee will review on a quarterly basis all payments made by the Company to the Sponsor, to the Company’s officers or directors, or to the Company’s or any of such other persons’ respective affiliates.

  • Joint Safety Committee (a) The Union and the Company shall cooperate in selecting one or more Safety Committees, which will meet at least once a month to consider all safety and occupational health problems. (b) The local Joint Safety Committee shall consist of equal representation from Company and Union. This Committee shall meet at least once a month to consider all safety and occupational health problems.

  • COMPLIANCE COMMITTEE (1) Within thirty (30) days of the date of this Agreement, the Board shall appoint a Compliance Committee of at least three (3) directors, of which no more than one (1) shall be an employee or controlling shareholder of the Bank or any of its affiliates (as the term “affiliate” is defined in 12 U.S.C. § 371c(b)(1)), or a family member of any such person. Upon appointment, the names of the members of the Compliance Committee and, in the event of a change of the membership, the name of any new member shall be submitted in writing to the Assistant Deputy Comptroller. The Compliance Committee shall be responsible for monitoring and coordinating the Bank's adherence to the provisions of this Agreement. (2) The Compliance Committee shall meet at least monthly. (3) Within sixty (60) days of the date of this Agreement and quarterly thereafter, the Compliance Committee shall submit a written progress report to the Board setting forth in detail: (a) a description of the action needed to achieve full compliance with each Article of this Agreement; (b) actions taken to comply with each Article of this Agreement; and (c) the results and status of those actions. (4) The Board shall forward a copy of the Compliance Committee's report, with any additional comments by the Board, to the Assistant Deputy Comptroller within ten (10) days of receiving such report.

  • Health & Safety Committee The Employer agrees to establish a Health & Safety Committee for all employees of the company under the auspices of the Occupational Health and Safety Act (OHSA). The Committee shall be made up of an equal number (not less than one each) of non-bargaining unit and bargaining unit persons who have completed their probationary period. The Union has the right to appoint the members representing the bargaining unit. The Committee shall keep minutes of its meetings and post them in the shop. One copy will be forwarded to the Union office.

  • Health and Safety Committee Where required a committee will be formed and will meet where required by the Employer’s safety policies and by statute.

  • Health and Safety Committees In order to provide a safe and healthful workplace, local unit level LMCs shall establish Health and Safety Committees. Each committee will be composed of an equal number of representatives appointed by the Union and the Employer and will be co-chaired by a Union and Employer representative. A Union representative must be a member of the unit but either party may be accompanied by staff and/or other subject matter experts who may participate, but not vote, at meetings. Each party shall prepare and submit an agenda to the other party one week prior to any scheduled meeting. If neither party submits an agenda, the meeting shall be canceled. Each committee’s general responsibility will be to provide a safe and healthful workplace by recognizing hazards and recommending the abatement of hazards and educational programs. Each committee will: 1. Meet on an established schedule; 2. arrange periodic inspections to detect, evaluate and offer recommendations for control of potential health and safety hazards; 3. appoint members of the committee to participate in inspections, investigations, or other established health and safety functions to the extent necessary; 4. receive and review a quarterly summary of job-related health and safety reports including accident reports and make appropriate recommendations; 5. investigate all types of employee job-related accidents and all types of occupational illnesses and make recommendations; 6. promote health and safety education; 7. study the use of VDTs and make appropriate recommendations to ensure the health and safety of employees regarding such use; 8. maintain and review minutes of all committee meetings; and 9. review the availability and adequacy of first aid supplies and equipment and address any inadequacies. In cases where summary reports are provided, a committee member may request and receive an individual case file or report. In no case will an employee’s records be provided when the law forbids disclosure. In addition, employees’ names will normally be deleted but may be provided to all committee members in instances where committee members need to know the name(s) of employee(s) to effectively represent the bargaining unit(s) and disclosure of name(s) is not prohibited by law. The Employer may require committee members and union representatives to sign confidentiality statements. Members of each Health and Safety Committee will be paid by the Employer while performing committee duties, including travel time, and will also be paid for any time spent in committee approved training related to health and safety. The Committee will develop an annual training program for its members. Each Health and Safety Committee will establish rules consistent with the above principles. A mechanism to coordinate the efforts of individual Health and Safety Committees will be established at each agency.

  • Joint Health and Safety Committee (a) The Employer and the Union agree that they mutually desire to maintain standards of occupational health and safety in the organization, in order to prevent accidents, injury and illness. The parties agree to promote health and safety throughout the organization. The employer shall provide orientation and training in health and safety to new and current employees on an ongoing basis, and employees shall attend required health and safety training sessions. (b) Recognizing its responsibilities under the applicable legislation, the Employer agrees to accept as a member of its Joint Health and Safety Committee, at least one representative from the bargaining unit. The number of committee members will be no less than that determined by legislation and the bargaining unit will be entitled to the same membership as any other employee group on the committees. The Union shall notify the employer of their representatives. (c) Such Committee shall identify potential dangers and hazards, institute means of improving health and safety programs, and recommend actions to be taken to improve conditions related to occupational health and safety. (d) The Employer agrees to cooperate reasonably in providing necessary information to enable the Committee to fulfill its functions. The Committee shall respect the confidentiality of the information. (e) The Union agrees to endeavour to obtain the full cooperation of its membership in the observation of all safety rules and practices. (f) Meetings shall be held every third month or more frequently at the call of either co-chair, if required. The Committee shall keep Minutes of all meetings and make the Minutes available for review. (g) All time spent by a member of the Joint Health and Safety Committee attending meetings of the Committee and carrying out the members duties, shall be deemed to be time worked for which the member shall be paid by the Employer at the member's applicable rate of pay, and the member shall be entitled to such time from the member's work as necessary for those duties. (h) The employer shall take every precaution reasonable in the circumstances for the protection of a worker. [Occupational Health and Safety Act, s. 25

  • Safety Committee Where a Health and Safety Committee is established on a job in accordance with section 72 of the OHS Act, it shall include the Employer’s Site Safety Supervisor and the Health and Safety Representative/s.

  • Safety Committees Joint employee-elected and Employer appointed safety committees shall be formed in accord with WISHA requirements and following University of Washington policy. The Union is entitled to representation on the University-wide or specific organizational or divisional committees where bargaining unit employees are working. Any department or unit committee also dealing with health and safety issues in work areas shall appropriately involve bargaining unit employees. Participation in safety and health committees, including meeting time, health and safety research, work on committee assignments, seminars, and classes will be considered time worked for all employees in accordance with University policy. Release time must be arranged with supervisors in advance. When the committee makes a recommendation that requires action or approval beyond its scope of authority, the Employer will communicate its disposition of the formal written recommendation within thirty (30) days.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

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