subject: Raps Pre-approved Webinar On changes To Good Pharmacovigilance Practices In The Eu [print this page] Description:From July 2012, a new legislation andguidance for pharmacovigilance has started to apply in the European Union (EU). These revised guidances and legislations will be the new standard in future.
To assist in their 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).
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.
This webinar will impart an understanding of these new guidances and legislations.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.
Areas Covered in the Session:
oPharmacovigilance systems
oReporting and Management of Adverse Reactions
oPeriodic Safety Update Reports
oPost Authorization Safety Studies
oChanges to Definitions
oThe Pharmacovigilance Risk Assessment Committee
Detailed Agenda of the Session:
oHow the new legislation will better protect patient safety
oHow the new legislation will affect Marketing Authorization Holders
oHow the new legislation will affect Sponsors of Clinical Studies
By whom: For the past nine years, Robert J. Russell 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, 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.
