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Business Process Optimization in Pharmacovigilance - Webinar By GlobalCompliancePanel

March 02, 2012

Pharma Development and Business

GlobalCompliancePanel, Online Training Thursday, March 15, 2012 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

Organized by:			GlobalCompliancePanel
Invited Speakers:			Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA. He has 25 years’ experience in drug safety & pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide. DLB was acquired by eResearch Technologies in 1997; since then Steve has worked as an independent consultant.

Deadline for Abstracts:			Thursday, March 15, 2012

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

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