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Essentials of Drug Safety and Pharmacovigilance  

Date & Time: Thursday, April 19, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 90 Minutes

Instructor: Steve Jolley

Location: Online

Price : $245.00

 

  

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(for one participant)

Instructor Profile:

Overview:

Steve Jolley Principal, SJ Pharma Consulting

This webinar is designed to give pharmaceutical and biologic companies operating in the U.S. and EU an introduction to the fundamentals of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities. Product safety makes headlines every day - and the impact on a company's image, consumer confidence, and Wall Street’s opinion is profound. While good safety data has historically been a prerequisite for product approval, recent media attention has intensified public and Congressional scrutiny and resulted in regulations such as the FDA Amendment Act and its strengthened requirements for monitoring post-marketing safety.You can be sure regulatory authorities will inspect your drug safety operations - and there is no excuse for poor preparation.

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An understanding of regulatory requirements for drug safety Knowledge of how to collect, assess, report and analyze adverse events An overview of creating signaling analyses based on FDA Good Pharmacovigilance Practices An engaging and experienced instructor Handouts to use for future reference Time for questions and answers

Click here to register for this webinar

 

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. ...more

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Who Will Benefit: l

Drug safety and pharmacovigilance

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Regulatory affairs Clinical development Executives (including C-Level) with any legal responsibility for

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drug safety

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

 


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Essentials of Drug Safety and Pharmacovigilance