Event Detail
Changes to Good Pharmacovigilance Practices in the EU - Webinar By GlobalCompliancePanel
August 14, 2012 - Online Training DE US
GlobalCompliancePanel
webinars@globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
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). Why should you attend: This webinar is focused on understanding the new requirements for Good Pharmacovigilance Practices that will begin to become effective in the European Union beginning July 2012. The New Guidance on Good Pharmacovigilance Practices (GVP) has been updated by Module, of which the first seven Modules have been disclosed for public consultation. This Course will describe the Regulatory Updates, Guidance Updates and thoughts on how some Member States’ Competent Authorities will proceed with implementation. These regulatory changes will also impact the EU Clinical Trial Directive and expectations of sponsors in the protection of patients and public health, before, during and after a clinical study. Areas Covered in the Session: Pharmacovigilance systems Reporting and Management of Adverse Reactions Periodic Safety Update Reports Post Authorization Safety Studies Changes to Definitions The Pharmacovigilance Risk Assessment Committee Detailed Agenda of the Session: How the new legislation will better protect patient safety How the new legislation will affect Marketing Authorization Holders How the new legislation will affect Sponsors of Clinical Studies Adverse Drug Reaction Reporting Periodic Safety Update Reports 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 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 industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry. Price List: Live : $245.00 Corporate live : $495.00 Recorded : $295.00