This webinar is an entry-level introduction to the basics of drug safety and phrmacovigilance.  In an environment of increased drug safety regulations, heightened public awareness of product safety and the need to keep products on the market without interruption as blockbuster drugs come to the end of their patented life, you need to know how to protect the safety of your products and avoid recalls.  Steve Jolley, a noted pharmacovigilance expert, will review regulatory requirements for drug safety, how to collect, assess, report and analyze adverse events and how to create signaling analyses based on best practices. 

Among the topics to be covered in this webinar are:

·         History of pharmacovigilance

·         Importance of adverse event reporting

·         Definition of adverse drug reaction

·         Pharmacovigilance process

·         Assessing adverse events

·         What and when to report

·         Signaling and data mining

This webinar will be a valuable learning experience for drug company managers responsible for drug safety, regulatory affairs and clinical 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.