GlobalCompliancePanelto organize RAPS pre-approved webinar on "Changes to Good Pharmacovigilance Practices in the EU"
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinaron the topic, "Changes to Good Pharmacovigilance Practices in the EU"onDecember 13.
- Fresno, CA (1888PressRelease) December 13, 2012 - 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:
o Pharmacovigilance systems
o Reporting and Management of Adverse Reactions
o Periodic Safety Update Reports
o Post Authorization Safety Studies
o Changes to Definitions
o The Pharmacovigilance Risk Assessment Committee
Detailed Agenda of the Session:
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
Periodic Safety Update Reports
Post-Authorization Safety Studies
o Eudravigilance Database
o Changes to labeling
o The Pharmacovigilance Risk Assessment Committee
o Implementation timing and expectations
When:December 13, 10:00 AM PDT | 01:00 PM EDT
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.
For whom:
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 Investigators
o Clinical Research Scientists
o QA / QC Auditors and Staff
o Consultants
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
www.globalcompliancepanel.com
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