This course 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.
Why should you attend:
Cost Issues: - Blockbuster drugs coming to end of patent life
- Keeping products on the market without interruption becomes more essential with reduced pipeline
- Current economic environment drives cost saving efforts
- Peaks and valleys in case processing workload emphasize the need to optimize expensive resources
Regulatory Issues: - Increased safety regulations by global government agencies
- Requirement for added safety data slows down the product approval process
- FDAAA enforces more stringent requirements for monitoring post-marketing safety
Public confidence issues: - Heightened public awareness of product safety
- Product safety reflects company image and consumer confidence
Areas Covered in the Session: The following aspects will be examined:
- Identify areas that require attention - strategy, planning, execution and control of case processing and signaling
- Reference processes for case processing and signaling
- Identify non-value added activities, redundancies, parallel and serial operations, cost-benefit of technology
- Align strategy, business process, metrics and SOPs
- Outsource/offshore strategy
- Identify compliance risks and inefficiencies in case intake, data entry, coding and evaluation, submissions.
- Signal assessment such as analysis of company data, comparison to FDA and WHO databases, prioritizing signals, case series analysis, medical significance of confirmed signal, preparing signal assessment report, and recommendations for label update.
- Use of signal triage algorithms such as disproportional reporting, positive re-challenge, rapid reporting increase, new drugs, serious reactions, and reactions of special interest.
- Compliance with FDA guidance as specified in Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, March 2005.
- Timing and frequency of signal detection, triage, and data mining runs.
Who Will Benefit: - Clinical Safety/Pharmacovigilance
- Quality management
- Clinical research & development
