Live Webinar
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Preparation for FDA & EU Pharmacovigilance Inspections
Date & Time: Tuesday, April 3, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Steve Jolley
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview: This webinar is designed to give pharmaceutical firms operating in the US and EU practical information, practices and insight to help ensure compliance with the most recent drug safety and pharmacovigilance regulations. Recent increased regulatory enforcement of drug safety makes it more important than ever that pharmaceutical manufacturers effectively evaluate their drug safety operations. l
Are your Good Pharmacovigilance Practices up-to-date and followed properly?
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Are you confident you can withstand a pharmacovigilance audit? And are you ready for the inevitable inspection by FDA and/or
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European Regulatory Authorities? You can be sure regulatory authorities will inspect your drug safety operations - and there is no excuse for poor preparation. Whether you're planning an internal audit of your processes, anticipating an audit from a business partner, or preparing for your FDA or EMA inspection, this webinar will give both old hands and new staff the down-to-earth, solid methods needed to be ready for regulatory scrutiny of your drug safety and pharmacovigilance specialists, safety processes, safety systems and reporting.
Steve Jolley Principal, SJ Pharma Consulting 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
Areas Covered in the Session: l
Why the pharmacovigilance audit is important to ensure Good Pharmacovigilance Practice
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The impact of global regulations on international safety reporting and review methods The objectives and components of a pharmacovigilance audit
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Practical steps to help you begin and implement your audit The requirements of all applicable regulatory bodies for your products
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Initiating company practices for drug safety across the product lifecycle
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Examples of what NOT to do
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Click here to register for this webinar Who Will Benefit: l l l l l
Clinical Safety Staff Pharmacovigilance Specialists Regulatory affairs Professionals Quality management Specialists Management involved in clinical oversight
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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