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
