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Live Webinar


Business Process Optimization in Pharmacovigilance

Date & Time: Thursday, March 15, 2012

10:00 AM PST | 01:00 PM EST

Duration: 90 Minutes

Instructor: Steve Jolley

Location: Online

Price : $245.00


Register Now

(for one participant)

Instructor Profile:


Steve Jolley Principal, SJ Pharma Consulting

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

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.

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: l

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 ¡ ¡


¡ ¡ ¡ ¡ ¡ ¡ ¡

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. ...more

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

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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Business Process Optimization in Pharmacovigilance  

This webinar will describe how to assess and optimize Pharmacovigilance operations from cost effective, compliance, and safety perspectives....

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