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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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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


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 www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Preparation for FDA & EU Pharmacovigilance Inspections  

This webinar is designed to give pharmaceutical firms operating in the US and EU practical information, practices and insight to help ensure...

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