New EU Pharmacovigilance Directive and Regulations 2013

Topics

• EU Pharmacovigilance : Why make changes now?
• Overview of EU Regulatory structure
• Organization of PV Modules
• New definitions for the updated directive and regulation
• Eudravigilance Database
• Update to the EU Pharmacovigilance legislation
• The Pharmacovigilance Risk Assessment Committee
• Changes to labeling
• Implementation timing & expectations

Who should Attend

• Project Managers
• Senior Management
• PV Reporting
• Clinical Trial Heads
• Project Managers
• Medical Writers
• QA / Compliance personnel
• CRAs and CRCs
• Clinical Research Scientists
• Investigators
• Consultants
• QA / QC Auditors and Staff