Changes to Good Pharmacovigilance Practices in the EU - Webinar By ComplianceOnline

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.

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.

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