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.

  • 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.

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

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

  • If there is no disagreement, the members of the specific boards for which the additional meeting is necessary are notified by the IRBMED Regulatory Team to verify the availability of a quorum.

  • The IRBMED Regulatory Team will also take meeting minutes to document IRB meeting attendance, reviews, discussion, outcomes, contingencies and determinations with regard to IRB meeting agenda items, federal and other state or local regulations, and IRBMED requirements.

  • 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.

  • Our Privacy and Regulatory Team is responsible for all lobbying activities and engaging with government officialsand policy makers on public policy initiatives.

  • 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 any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

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

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • 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, as applicable.

  • 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 Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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 shall have the meaning set forth in Section 3.4.1.

  • 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 service approved by the London Stock Exchange for the distribution to the public of announcements; and

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • JPC means Joint Planning Committee.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).