Module 6

03/10/2024

High-level PV process (from safety data via signals to SmPC)

Non Clinical Data and Clinical Study & Epidemiology Data & Reports

Expedited Reports

Issue Management

Literature Reports

Spontaneous Reports

Collect Data

Collate (database)

Data Review & Analysis

Expedited Reporting

ACTION

Study & PMS Data

Risk Management Plans

Aggregate Reports

Follow-up

Regulatory Reports

Phase 1 – Core PV Processes Phase 2 Alignment for inputs and single case outputs Phase 3 Medical Safety and benefit risk assessment

15

15

ICSRs: Assessment of seriousness

Labelled Event

Reported Event

Serious?

Paramedic Resuscitating Heart

Myocardial infarction

Cardiac arrest requiring defibrillation

Suicidal ideation

Patient took six paracetamol tablets

Poison

Aggressive reactions

Patient was psychotic – assaulted a police officer

Weight gain

Patient put on 25kg in weight over 6 months

16

16

8