MAIN TOPICS

• Ethics in clinical trials and in pharmacovigilance
• Medication errors
• Epidemiology and statistics:
• Signal detection and CIOMS VIII
• Large simple trials
• Are registers appropriate tools in Post Authorization Safety Studies (PASS) and Post Authorization Efficacy Studies (PAES)?
• Type of registers, requirements, value, pro's and con's
• Off-label use
• Risk perception and communication
• Antidiabetic treatment and pharmacovigilance after rosiglitazone:
• Benefit of pharmacotherapy - quantitative and qualitative comparisons,
• Clinical and epidemiological trials and value of surrogate parameters
• Pharmacogenomics
• Monoclonals - pharmacovigilance and safety problems
• Special patients groups: children, elderly, gender aspects
• Vaccines and vaccination programmes
• H1N1: lessons learned
• Education and training
• Planning pharmacovigilance and Risk Management Plans
• The human factor in risk assessment and decision making through patients, physicians, or regulators
• Weighing benefit and harm, chance and risk.
• Beje Wiholm lecture
• ISoP's national and regional chapters' meetings