PV legislation
Collection of information
Analysis and understanding
Regulatory Action
Communication
RMP
PSUR
ADR
PASS
PMSF
MEDICAL LITERATURE MONITORING
NOTIFICATION OF WITHDRAWLS
ARTICLE 57 DATABASE
Additional monitoring
Stengthening signal detection
Improved eudravigilance
PRAC
Agendas,minutes,coordination of safety messages,public hearings
EC have reviewed twice,good and bad.Industry issued joint press statement outlining issues,huge cost,increased centralised role and deskilling of NCA,cultural shift to reporting,time spent on communication and not assessment
Obligatory