Description

Summary: A RAPS pre-approved webinar on the topic, “Changes to Good Pharmacovigilance Practices in the EU” is being held by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on August 14. The speaker of this 90-minute webinar, which earns 1.5 RAC credits for its participants towards a participant's RAC recertification upon full completion, will be Robert J. Russell, President of RJR Consulting, Inc.

Description : From July 2012,the European Union (EU) will be governed by new Legislation & Guidance for Pharmacovigilance. 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).

The webinar will benefit
o Senior Management
o Project Managers
o Clinical Trial Heads
o PV Reporters
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