Review of Inquiries Made to Medical Affairs Group Sample Clauses

Review of Inquiries Made to Medical Affairs Group. InterMune has in place a policy addressing the discussion and dissemination of information about non-FDA approved uses of products (off-label information). This policy provides, among other things, that Covered Persons may not directly or indirectly solicit, encourage, or promote unapproved uses of a product to HCPs. InterMune also has established a Medical Affairs unit to respond to requests for information about off label uses of InterMune products. a) Information To Be Included in Medical Affairs Inquiries Database InterMune shall document and record all inquiries that Medical Affairs receives from HCPs regarding Actimmune or other InterMune products in a database (Medical Affairs Inquiries Database). Medical Affairs shall record in the Medical Affairs Inquiries Database the following information about each unique inquiry (Inquiry) received for information about InterMune’s products: 1) date of inquiry; 2) form of inquiry (e.g., fax, phone, etc.); 3) name of requesting HCP; 4) nature and topic of request (including exact language of the inquiry if made in writing); 5) an evaluation of whether the inquiry relates to information about an off-label indication for the product; 6) nature/form of the response from InterMune (including a record of the materials provided to the HCP in response to the request); 7) the name of the InterMune representative who called on or interacted with the HCP; and 8) the status and findings of any follow-up review conducted by InterMune in situations in which improper off-label promotion is suspected. b) Internal Review of Medical Affairs Inquiries Database On a semi-annual basis, the Compliance Officer or other appropriate personnel shall review the Medical Affairs Inquiries Database and related information, as appropriate, and shall generate a report summarizing the items of information outlined in Section III.A.1.a above for each Inquiry handled by Medical Affairs during the preceding two, quarters (the Medical Affairs Inquiry Report). On a semi-annual basis, the Compliance Officer shall review the Medical Affairs Inquiry Reports to assess whether the information contained in the report suggests that improper-off—label promotion may have occurred in connection with any Inquiry(ies). If the Compliance Officer, in consultation with other appropriate InterMune personnel, suspects that improper off-label promotion may have occurred in connection with one or more Inquiries, the Compliance Officer shall undertake a follow-up revi...
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Related to Review of Inquiries Made to Medical Affairs Group

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  • Procurement Related Complaints and Administrative Review 49.1 The procedures for making a Procurement-related Complaint are as specified in the TDS. 49.2 A request for administrative review shall be made in the form provided under contract forms.

  • Research Independence The Company acknowledges that each Underwriter’s research analysts and research departments, if any, are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriter’s research analysts may hold and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of its investment bankers. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against such Underwriter with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriter’s investment banking divisions. The Company acknowledges that the Representative is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short position in debt or equity securities of the Company.

  • Clinical Management for Behavioral Health Services (CMBHS) System 1. request access to CMBHS via the CMBHS Helpline at (000) 000-0000. 2. use the CMBHS time frames specified by System Agency. 3. use System Agency-specified functionality of the CMBHS in its entirety. 4. submit all bills and reports to System Agency through the CMBHS, unless otherwise instructed.

  • Sub-Advisor Compliance Policies and Procedures The Sub-Advisor shall promptly provide the Trust CCO with copies of: (i) the Sub-Advisor’s policies and procedures for compliance by the Sub-Advisor with the Federal Securities Laws (together, the “Sub-Advisor Compliance Procedures”), and (ii) any material changes to the Sub-Advisor Compliance Procedures. The Sub-Advisor shall cooperate fully with the Trust CCO so as to facilitate the Trust CCO’s performance of the Trust CCO’s responsibilities under Rule 38a-1 to review, evaluate and report to the Trust’s Board of Trustees on the operation of the Sub-Advisor Compliance Procedures, and shall promptly report to the Trust CCO any Material Compliance Matter arising under the Sub-Advisor Compliance Procedures involving the Sub-Advisor Assets. The Sub-Advisor shall provide to the Trust CCO: (i) quarterly reports confirming the Sub-Advisor’s compliance with the Sub-Advisor Compliance Procedures in managing the Sub-Advisor Assets, and (ii) certifications that there were no Material Compliance Matters involving the Sub-Advisor that arose under the Sub-Advisor Compliance Procedures that affected the Sub-Advisor Assets. At least annually, the Sub-Advisor shall provide a certification to the Trust CCO to the effect that the Sub-Advisor has in place and has implemented policies and procedures that are reasonably designed to ensure compliance by the Sub-Advisor with the Federal Securities Laws.

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

  • TRAINING AND EMPLOYEE DEVELOPMENT 9.1 The Employer and the Union recognize the value and benefit of education and training designed to enhance an employee’s ability to perform their job duties. Training and employee development opportunities will be provided to employees in accordance with Employer policies and available resources. 9.2 Attendance at employer-required training will be considered time worked. The Employer will make reasonable attempts to schedule employer-required training during an employee’s regular work shift. The Employer will pay the registration and associated travel costs in accordance with Article 23, Travel, for employer-required training.

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