Changes to good pharmacovigilance practices in EU

Overview: New Legislation and 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 Authorisation 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 Authorisation Holders
How the new legislation will affect Sponsors of Clinical Studies
Adverse Drug Reaction Reporting
Periodic Safety Update Reports
Post-Authorisation Safety Studies
Eudravigilance Database
Changes to labelling
The Pharmacovigilance Risk Assessment Committee
Implementation timing and 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 nine 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.

Event Link - http://alturl.com/rmdp4

Venue

Date: 14 August 2012
Time: 10:00 AM - 11:30 AM
Location: Online Training, Wilmington
Cost: Live : $245.00,Corporate live : $495.00,Recorded : $295.00
More info: Online Training

Contact: GlobalCompliancePanel
Company name: GlobalCompliancePanel
Telephone number: 8004479407
Email address