Overview:
This webinar will describe how to assess and optimize Pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings.
The methodology has helped companies increase compliance at reduced cost. The scope covers all Pharmacovigilance activities: case processing activities such as case intake, data entry, assessment and reporting and signaling activities such as signal detection, evaluation and risk management.
Areas Covered in the Session:
- Current Pharmacovigilance Environment
- Issues facing biopharmaceuticals
- Key pharmacovigilance Business Process Areas
- Detailed pharmacovigilance Issues
- Managing Business Processes
- Overview of Pharmacovigilance process
- High-level reference business process for Case processing and signaling
- Pharmacovigilance business process maturity
- Why Optimization follows Improvement
- Importance and role of metrics
- Framing the business process improvement - case for action
- Project structure – who and when to involve
- Business Process Management – what it is and why is it important
- How to Improve and Optimize Case Processing
- Planning - the first step
- Control - the final say
- Process Improvement Methodology - assessment and improvement
- Assessing case processing - flow charts and pain points
- Improving case processing - identify redundancies, duplications, multiple inspections, mismatched accountabilities and responsibilities
- Optimizing case processing - Allocating activities to resources
- Simulation and dynamic optimization - what-if scenarios
- Implementation challenges
- How to Optimize Signaling
- Reference Pharmacovigilance Process
- Impact of size of company
- Planning Signaling Operations
- Signal detection process optimization
- Signal evaluation process optimization
- Risk management process optimization
- Timing and frequency of signal detection, triage, and data mining runs
Learning Objectives:
- Assess current Pharmacovigilance environment - case processing and signaling
- Identify areas of improvements - redundancies, automating manual intensive operations, over/under inspections
- Implement metrics and organization change management, including critical success factors
- Identify obstacles to implementation
- Evaluate pros and cons of outsourcing / off-shoring
Who Will Benefit:
- Clinical Safety/Pharmacovigilance
- Quality Management
- Clinical Research & Development
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