Regulatory Team definition

Regulatory Team means the department within The FA with responsibility for overseeing compliance with the Salary Cap Regulations.

Examples of Regulatory Team in a sentence

  • Please contact Council’s Compliance & Regulatory Team (RMACompliance@rotorualc.nz) in relation to the completion and monitoring of the conditions of this consent.

  • The Regulatory Team will need to be able to confirm that these payments are genuine and legitimate and that a Club is not ‘re-directing’ funds to a Player via this route and thereby reducing the Salary Cap Value of a Player.

  • Where such a request is made, advice should be sought from the Star Central Regulatory Team.

  • The Regulatory Team has been providing pre-application support in relation to other significant applications that are due to be lodged within the next 12 months.

  • The Regulatory Team will be reviewing these reports and assessing compliance.

  • The IRBMED Regulatory Team will evaluate whether an actual or perceived COI exists prior to contacting a consultant and also ask the consultant to disclose any perceived, potential, or actual conflicts.

  • The use of services is from 9:00 to 21:00 on weekdays unless there is a particular obstacle in the business or technology of the company.

  • On the day of, and in advance of each convened IRB meeting, the IRBMED Regulatory Team will oversee IRB meeting room facilities and supplies; the set-up of audio/visual projection equipment, laptop or notebook computers, and vote cards (as appropriate) for members, alternate members and others.

  • The IRBMED Regulatory Team will provide support to the IRB by electronic projection of each agenda item for discussion, and any additional supporting or backup documents as needed.

  • Prior to a Single Member review (SMR) of an AE or ORIO, or expedited review, the IRBMED Regulatory Team will assess the application to determine, to the extent possible, whether the reviewer has a COI.

Related to Regulatory Team

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • JSC has the meaning set forth in Section 3.1.

  • Regulatory Oversight Committee means the committee of the Board constituted in accordance with Rule 204.

  • JDC has the meaning set forth in Section 3.2.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • JCC has the meaning set forth in Section 2.1.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • JRC has the meaning set forth in Section 2.1.1.

  • Development Committee has the meaning set forth in Article 3 of the Amended and Restated Research and Development Agreement.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Information Service means a regulatory information service as defined in the FCA Handbook;

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Development Plan has the meaning set forth in Section 3.2.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • JPC means Joint Planning Committee.

  • Regulatory Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.