Pharmacovigilance 2013

Key Topics

• Surveillance of adverse drug reactions in clinical trials
• Insight into pharmacovigilance throughout the product lifecycle, from clinical development to patient care
• Risk management plans for improving drug safety
• Pharmacovigilance activities in biopharmaceutical product development
• Current and changing regulations in the EU
• Good pharmacovigilance practice through advances in audits and inspections
• Post marketing surveillance
• How the role of the QPPV impacts patient safety
• The use of Periodic Safety Update Reports (PSURs) post-authorisation for safety signals
• Current methods of reporting
• Pharmacogenetics and the potential for personalised medicines
• Principles of signal detection in pharmacovigilance

Who should Attend

VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:

• Pharmacoepidemiology
• Pharmacovigilance
• Drug/Product Safety
• Pharmacogenomics
• Information and Clinical Data Management
• Drug Development
• Clinical Safety
• Clinical Pharmacology
• Risk Management
• Periodical safety update reports
• Quality Assurance
• Research & Development
• Signal Detection
• Patient Safety
• Outcomes Research
• Safety Surveillance
• Epidemiology
• Data Analysis
• Medical Affairs