Promotional and Product Related Functions Systems Review Sample Clauses

Promotional and Product Related Functions Systems Review. The Promotional and Product Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Indivior relating to Promotional Functions, Product Related Functions, and other systems as described below. Where practical, Indivior personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Indivior in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Indivior associated with the following (hereafter “Reviewed Policies and Procedures”): 1. Indivior’s systems, policies, processes and procedures applicable to the manner in which sales representatives and personnel from Medical Affairs handle requests or inquiries relating to information about the uses of Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses of Government Reimbursed Products) and the dissemination of materials relating to the uses of these products. This review shall include: (a) the manner in which Indivior sales representatives handle requests for information about off-label uses of Government Reimbursed Products, (b) the manner in which Medical Affairs personnel, including those at Indivior’s headquarters, handle and respond to requests for information about off-label uses of Government Reimbursed Products; (c) the form and content of information and materials related to Government Reimbursed Products disseminated to HCPs, HCIs, payors, and formulary decision-makers by Indivior; (d) the systems, processes, policies, and procedures to track requests to Medical Affairs for information about off-label uses of products and responses to those requests; (e) the manner in which Indivior collects and supports information reported in any systems used to track and respond to requests to Medical Affairs for Government Reimbursed Product information; (f) the processes and procedures by which Medical Affairs or other appropriate individuals within Indivior identify situations in which it appears that off-label or other improper promotion may have occurred; and (g) Indivior’s processes and procedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potentia...
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Promotional and Product Related Functions Systems Review. The Promotional and Product Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Indivior relating to Promotional Functions, Product Related Functions, and other systems as described below. Where practical, Indivior personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Indivior in accordance with the preceding sentence.
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Promotional and Product Related Functions Systems Review. The Promotional and Product Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Novartis relating to Promotional Functions, Product Related Functions, and other systems as described below. Where practical, Novartis personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Novartis in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Novartis associated with the following (hereafter “Reviewed Policies and Procedures”): 1. Novartis’ systems (including any centralized electronic systems), processes, policies, and procedures relating to External Speaker Programs as defined and described in Sections III.B.2.i and Section III.L.1 including but not limited to systems, processes, policies and procedures relating to the identification, selection, and approval of External Speakers, the timing and implementation of External Speaker Programs, the amounts paid to External Speakers, the expenses incurred or amounts paid by Novartis for travel and travel-related expenses in connection with External Speaker Programs, the tracking of amounts paid to External Speakers and the amounts spent on travel and travel- related expenses, and the External Speaker Monitoring Program; 2. Novartis’ systems (including any centralized electronic systems), processes, policies, and procedures relating to Internal Speaker Programs as defined and described in Sections III.B.2.i and Section III.L.2 including but not limited to systems, processes, policies, and procedures relating to decisions to hold Internal Speaker Programs, the identification of Internal Speakers, and the implementation of Internal Speaker Programs (including the venue of such programs); 3. Novartis’ systems, processes, policies, and procedures relating to the engagement of HCPs or HCIs to serve as consultants or for other fee-for-service arrangements (including, but not limited to, presentations, appearances in Novartis- sponsored communications and materials, consultant task force meetings, advisory boards, preceptorships, mentorships, and ad hoc advisory activities, and any other financial engagement) and all events and exp...
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