Current Challenges Pharmacovigilance

Introduction: background; privacy and the protection of personal health data; overview. Sources of individual case reports: spontaneous reports from persons other than healthcare professionals; literature; the Internet; solicited reports; aspects of clinical trials reports; epidemiology; disease-specific registries and regulatory ADR databases; licensor-licencee interactions. Good case management practices: assessing patient and reportor identifiability; criteria for seriousness; criteria for expectedness; case follow-up approaches; role of narratives. Good summary reporting practices PSURs reconsidered: results of a survey on PSUR workloads; proposals for PSUR content modification; proposals relating to frequency and timing of reporting; miscellaneous proposals for managing PSURS. Determination and use of population exposure data: periodic safety update reports and exposure data sources; technical considerations; spontaneous reporting and patient exposure; real examples of denominator determination and use; patient-exposure and measurments of risk. Clinical safety reporting regulations - an overview: basis for comparison of regulations; current atate of affairs; recommendations; conclusion. Summary of proposals.