Fremont, California (PressExposure) March 22, 2013 -- Description:
Starting July 2012, changes governing Good Pharmacovigilance Practices (GVP) brought about by the EU started kicking in. The EU is writing a series of Guidance Documents to assist in the implementation of GVP with all stakeholders such as sponsors, applicants and license holders. This new series will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU. In addition, there has been an update of the legal framework for pharmacovigilance on Medicinal Products for Human Use.
The EU has made changes into provisions of the GVP in a module-wise manner. The first seven modules have been made available to the public for consultation so far.
This webinar will give participants an understanding of what these seven modules mean to the industry.The Regulatory Updates, Guidance Updates and other related updates and an illustrationof how some Member States' Competent Authorities will go ahead with implementation will be taken up for discussion.
Clinical trials are one of the areas likely to be influenced by these new changes, because these new changes will impact the EU Clinical Trial Directive, as well as the expectations of sponsors in the protection of patients and public health, before, during and after a clinical study.
This webinar will discuss the impact this will have on the industry.
This webinar will cover the following areas:
o Overview of EU Regulatory structure
o EU Pharmacovigilance: Why make changes now?
o New definitions for the updated directive and regulation
o Organization of PV Modules
o Update to the EU Pharmacovigilance legislation
o How the new legislation will better protect patient safety
o How the new legislation will affect Marketing Authorization Holders
o How the new legislation will affect Sponsors of Clinical Studies
o Adverse Drug Reaction Reporting
o Periodic Safety Update Reports
o Post-Authorization Safety Studies
o Eudravigilance Database
o Changes to labeling
o The Pharmacovigilance Risk Assessment Committee
o Implementation timing & expectations
When:April 9, 10:00 AM PDT | 01:00 PM EDT
Robert J. Russell is 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, and 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.
The webinar will benefit
o Senior Management
o Project Managers
o Clinical Trial Heads
o PV Reporting
o Medical Writers
o Project Managers
o CRAs and CRCs
o QA/Compliance personnel
o Clinical Research Scientists
o QA/QC Auditors and Staff
Duration: 90 minutes
To enroll for this webinar, contact