Topics
- Surveillance of adverse drug reactions in clinical trials
- Pharmacovigilance from clinical development to patient care
- Risk management plans for improving drug safety
- Pharmacovigilance activities in biopharmaceutical product development
- Regulations in the EU, US and Asia
- Good pharmacovigilance practice through advances in audits and inspections
- Post marketing surveillance
- The role of the QPPV and patient safety
- Periodic Safety Update Reports (PSURs)
- Methods of reporting
- Pharmacogenetics and the potential for personalised medicines
- Signal detection in pharmacovigilance
Who should Attend
Managers, executives, Consultants and Scientific Advisors involved in 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, Regulatory Affairs and Compliance, Medical Affairs, Sales and Marketing and Information technology.
