by complianzworld.com 2014 - Changes to Good Pharmacovigilance Practices in the EU

Description:
New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) . 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).
Course Objective:
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
Course Outline:
Key Topics to be Discussed:
Pharmacovigilance systems
Reporting and Management of Adverse Reactions
Periodic Safety Update Reports
Post Authorization Safety Studies
Changes to Definitions
The Pharmacovigilance Risk Assessment Committee
Learning Objectives:
Upon completion of this course, attendees will have a thorough knowledge of the updated framework surrounding Good Pharamcovigilance Practices (GVP). This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation. The content of this course is designed to simplify the understanding of the new requirements and to provide attendees with the latest information on what the European Commission believes is a significant area of improvement in the region.
Target Audience:
This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology and CRO industry involved in maintaining Compliance across the responsibilities in European Pharmacovigilance such as:
Senior Management
Project Managers
Clinical Trial Heads
PV Reporting
Medical Writers
CRAs and CRCs
QA / Compliance personnel
Investigators
Clinical Research Scientists
QA / QC Auditors and Staff
Consultants
Speaker : Robert J. Russell
Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process. Prior to entering the consulting field.
Price List:
Live : $299.00
Group : $799.00
Recorded : $299.00
Training CD-DVD :$ 399.00
webinarhelpatcomplianzworld.com
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