This webinar will describe how to assess and optimize pharmacovigilance operations from cost effectiveness, compliance and safety perspectives.  It will help you identify areas that need improvement, approaches to assessments and improvements, and implementation practices and challenges.  Business processes related to case processing (pre and post-NDA approval) and signaling will be presented.  Steve Jolley, a noted expert in pharmacovigilance, will lead this advanced-level webinar so that participants can:

• Assess current pharmacovigilance environment - case processing and signaling

• Implement improvements – redundancies, automating manual intensive operations, over/under inspections

• Manage metrics and organization change, including critical success factors

• Identify obstacles to implementation

• Evaluate pros and cons of outsourcing and offshoring

This webinar will cover, among other things:

• Current Issues in pharmacovigilance

• Understanding and improving pharmacovigilance processes

• Reference case processing and signaling process models

• Key differences between improvement and optimization

• Process analysis and optimization: Classic approaches, monitoring, and simulation

• Global and local processes

• Change management – stakeholders within and outside pharmacovigilance

• Metrics – none, too few, too many, how many

• Supplementing the workforce

• Case studies and lessons learned

Clinical safety/pharmacovigilance officers and managers involved with quality management, clinical research and development.

INSTRUCTOR PROFILE

Steve Jolley, CEO of SJ Pharma Consulting, has over 25 years’ experience in drug safety and pharmacovigilance.  Steve is a specialist in global safety compliance and signal detection. Steve:

·         Has worked with over 50 clients in the US, Europe and Japan

·         Has led over 30 drug safety and pharmacovigilance audits and assessments

·         Has developed a 50-page PV checklist that covers the areas of strategy, organization structure, quality processes, SOPs, systems and risk management with references to the applicable law, regulation or guidance and best practices

·         Is a featured speaker with the FDA at DIA conferences and webinars on auditing, signaling and data mining.

Steve Jolley
SJ Pharma Consulting
Tel: 973-543-0622
Fax: 973-294-8118
steve@sjpharmaco.com

* 90-minute webinar (Travel-Free) delivered over the phone and Internet.
* Unlimited listeners per connection - bring the entire department.
* Q&A session with the expert.

This event will be presented live by phone together with a PowerPoint presentation to be viewed on your computer. Internet access is not required for phone-only participants. The PowerPoint slides will be provided shortly before the event. Once you register, you will receive an email which is your receipt and which includes your instructions for dialing in and logging on. You will also receive an email reminder 24 hours before the webinar.