System checkup

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System checkup

  1. 1. Check up on PV system<br />Gregory Fiore, MD<br />Confidential – for<br />Internal use only<br />
  2. 2. Goals and Approach<br />Goals<br />Quickly gain understanding of the overall safety system<br />Develop early hypothesis on possible risk areas <br />Prioritize areas for deeper dives<br />Approach<br />Establish governance for project<br />Review Organization<br />Review Safety System, including decision authority<br />Review Performance, including metrics, etc.<br />Review Safety Issues, for key products<br />
  3. 3. Establish project governance<br />Should be L+2 for safety head (if possible)<br />Should include key stakeholders (CMO, Medical Affairs, R&D, ?Legal, Compliance, Regulatory Affairs)<br />Determine frequency of touching base<br />Determine format for interaction<br />Establish framework including what is and is not in scope<br />
  4. 4. Approach - Organization<br />Perform 360 with internal stakeholders (key external stakeholders if agreed) to determine value and effectiveness of current system<br />Client to provide names, executives ensure access<br />Develop structured survey<br />Review backgrounds of key PV staff, including training records (if feasible)<br />Goal to ensure any gaps are identified and addressed<br />Review organizational structure and geography<br />Review all governance processes overseeing safety<br />Review documents describing roles/responsibilities as well as Job Descriptions<br />Review SPS or DDPS<br />Review written procedures<br />Understand geographic footprint, including competencies such as “centers of excellence”<br />
  5. 5. Approach – Safety System<br />Review DDPS and all written procedures<br />Review internal and external communication processes<br />Process map<br />Including all geographies <br />Including all sources (internal, external, etc.)<br />Including all “customers” of information<br />Including all variations (case type, etc.)<br />Including all partnership<br />Catalog and understand all technical applications<br />Ensure proper documentation, deep dive if requested<br />
  6. 6. Approach – Performance<br />Review system in place to monitor performance<br />Individual<br />Site<br />By product, etc.<br />Escalation process<br />Quality<br />Internal metrics<br />Feedback from customers<br />Audits/inspections<br />
  7. 7. Approach – Safety Issues<br />Review product safety issues<br />Entire portfolio vs. targeted (size dependant?)<br />Status (ongoing, closed, active, urgent)<br />Response system<br />
  8. 8. Next steps<br />Synthesize<br />Formulate high level recommendations<br />Design implementation strategy, including change management approach if necessary<br />Implement<br />Measure degree of success<br />Iterate<br />
  9. 9. Components of PV System<br />QPPV and the back-up procedure to apply in their absence.<br />Organization of the pharmacovigilance system describing the names, location and internal connections of the departments involved in pharmacovigilance activities within the company. <br />A charter of the organizational structure should also illustrate the cooperation with external partners.<br />Databases, listing of the data bases used for pharmacovigilance services, registration with the Eudravigilance system and description of processes used for (electronic) reporting.<br />Contractual arrangements with other persons or organizations involved in the fulfillment of pharmacovigilance obligations.<br />Training, recording regular education and further training of the staff involved in pharmacovigilance activities.<br />Documentation, description of the locations of the different types of pharmacovigilance source documents, including archiving arrangements/retention process.<br />Quality Management System.<br />Supporting Documentation<br />Labeling process (IB updates, frequency and process, labels, CCDS, etc.)<br />

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