Regulatory Team definition

Regulatory Team means the department within The FA with responsibility for overseeing compliance with the Salary Cap Regulations.
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Examples of Regulatory Team in a sentence

  • The IRBMED Regulatory Team will assure that Board members have adequate time to review all aspects of the submissions for review.

  • 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 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.

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

  • The IRBMED Regulatory Team and primary reviewer must complete their Reviewer Checklists prior to presentation to the convened IRB.

  • Additional information will also be provided to all board members by the IRBMED Regulatory Team at the time of the convened meeting, including, but not limited to, continuing educational presentations and other relevant information to assist them in serving on the board.

  • 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.

  • 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.

  • 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.

  • 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.

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 any pricing or reimbursement approvals, as applicable, 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 documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to the Licensed Product, including any documents submitted to any Regulatory Authority, including INDs, Regulatory Approval Applications, and all correspondence with any Regulatory Authority with respect to any Licensed Product (including minutes of any meetings, telephone conferences, or discussions with any 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 Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • JCC has the meaning set forth in Section 3.1.

  • 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 any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • 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 and all regulatory applications, filings, approvals and associated correspondence required to Develop, manufacture, market, sell and import Products in, or into, each country or jurisdiction in the Territory.

  • JRC has the meaning set forth in Section 2.2.

  • 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 and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable 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 any information service authorised from time to time by the FCA for the purpose of disseminating regulatory announcements;

  • 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 regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.