2012 - Business Process Optimization in Pharmacovigilance - Webinar By GlobalCompliancePanel

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
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884