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Live Webinar EU Pharmacovigilance Directive and Regulations Date: Wed, December 10, 2014 Instructor:Robert J. Russell
Time: 10:00 AM PST | 01:00 PM EST Location: Online
Duration: 90 Minutes
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Course "EU Pharmacovigilance Directive and Regulations " has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
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.
Areas covered in the session: Overview of EU Regulatory structure EU Pharmacovigilance : Why make changes now? New definitions for the updated directive and regulation Organization of PV Modules Update to the EU Pharmacovigilance legislation ยก How the new legislation will better protect patient safety ยก How the new legislation will affect Marketing Authorization Holders ยก How the new legislation will affect Sponsors of Clinical Studies ยก Adverse Drug Reaction Reporting n Periodic Safety Update Reports n Post-Authorization Safety Studies Eudravigilance Database Changes to labeling The Pharmacovigilance Risk Assessment Committee Implementation timing & expectations
Who Will Benefit: Senior Management Project Managers Clinical Trial Heads PV Reporting Medical Writers Project Managers CRAs and CRCs QA / Compliance personnel Investigators Clinical Research Scientists QA / QC Auditors and Staff Consultants
About Speaker Robert J. Russell President, RJR Consulting, Inc. Robert J. Russell For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past
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