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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.
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Live Webinar on
Essentials of Drug Safety and Pharmacovigilance
Date & Time:
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.
l An understanding of regulatory requirements for drug safety
l Knowledge of how to collect, assess, report and analyze
adverse events
l An overview of creating signaling analyses based on FDA Good
Pharmacovigilance Practices
l An engaging and experienced instructor
l Handouts to use for future reference
l Time for questions and answers
Click here to register for this webinar
l Drug safety and pharmacovigilance
l Regulatory affairs
l Clinical development
l Executives (including C-Level) with any legal responsibility for
drug safety
Thursday, April 19, 2012 10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes Instructor: Steve Jolley
Location: Online Price : $245.00 (for one participant)
Overview:
Areas Covered in the Session:
Who Will Benefit:
Register Now
Instructor Profile:
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
Steve Jolley
Principal, SJ Pharma
Consulting
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Your Necessity is our Priority
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
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