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