VIEWS: 73 PAGES: 2 CATEGORY: Healthcare & Medicine POSTED ON: 7/5/2012
Overview: New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU. The legal framework for pharmacovigilance on Medicinal Products for Human Use has now been updated, through an amended EU Regulation (No 1235/2010) and Directive (2010/84/EC).
RAPS Approved Webinar on Changes to Good Pharmacovigilance Practices in the EU Date & Time: Course "Changes to Good Pharmacovigilance Practices in the EU" has been pre-approved by RAPS as eligible for up to 1.5 Register Now credits towards a participant's RAC recertification upon full completion. Instructor Profile: Tuesday, August 14, 2012 10:00 AM PDT | 01:00 PM EDT Robert J. Russell Duration: 90 Minutes Instructor: Robert J. Russell President, RJR Consulting, Inc. Location: Online Price : $245.00 (for one participant) Robert J. Russell, For the past 9 years, Bob has been President of Overview: RJR Consulting, Inc. The company New Legislation & Guidance for Pharmacovigilance will apply in the assists the pharmaceutical, medical European Union (EU) beginning July 2012. To assist in its device and biotech industries in implementation with sponsors, applicants and license holders, a understanding and complying with International Regulations affecting series of Guidance Documents is being written, which will replace the compliance, new product current set of Volume 9A of the Rules Governing Medicinal Products in development, manufacturing and the EU. The legal framework for pharmacovigilance on Medicinal quality assurance. RJR has offices in Products for Human Use has now been updated, through an Columbus, OH, Washington, DC, amended EU Regulation (No 1235/2010) and Directive (2010/84/EC). Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past Areas Covered in the Session: industry experience as a CMC specialist, R&D Director and Global l Pharmacovigilance systems Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals l Reporting and Management of Adverse Reactions and Cordis-Dow medical devices. He l Periodic Safety Update Reports has a BS / MS degree in Chemistry. l Post Authorization Safety Studies ...more l Changes to Definitions l The Pharmacovigilance Risk Assessment Committee Suggest a Topic More Webinars Click here to register for this webinar Your Necessity is our Priority Who Will Benefit: l Senior Management l Project Managers l Clinical Trial Heads l PV Reporting l Medical Writers l Project Managers l CRAs and CRCs l QA / Compliance personnel l Investigators l Clinical Research Scientists l QA / QC Auditors and Staff l Consultants 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
"Changes to Good Pharmacovigilance Practices in the EU - Webinar By GlobalCompliancePanel"