EU Pharmacovigilance Directive and Regulations

New Legislation & 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.

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.

Areas Covered in the Session:

• Overview of EU Regulatory structure
• EU Pharmacovigilance : Why make changes now?
• New definitions for the updated directive and regulation
• Organization of PV Modules
• Update to the EU Pharmacovigilance legislation
  • How the new legislation will better protect patient safety
  • How the new legislation will affect Marketing Authorization Holders
  • How the new legislation will affect Sponsors of Clinical Studies
  • Adverse Drug Reaction Reporting
    • Periodic Safety Update Reports
    • Post-Authorization Safety Studies
      
• Eudravigilance Database
• Changes to labeling
• The Pharmacovigilance Risk Assessment Committee
• Implementation timing & expectations

• 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