The document discusses pharmacovigilance, which involves monitoring the safety of medicinal products to detect and assess adverse effects. It explains the workflow for pharmacovigilance, including data acquisition, signal detection, and risk management, emphasizing the need for systematic processes and collaborative signal assessment. Additionally, it outlines the importance of risk management plans and strategies for risk reduction in specific sub-populations.

1. i3 ConsultIntegrated Intelligence for Healthcare Industries
Pharmacovigilance
Challenges & Opportunities

2. i3 Consult
What is Pharmacovigilance?
Some etymology;
 Greek root “Pharmakon” means “Medicinal Substance”
 Latin root “Vigilia” means “To keep watch over”
A formal definition;
 WHO: The science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other drug-related
problem.

3. i3 ConsultEverything in Pharma Has a System
According to the EMA:
A pharmacovigilance system is defined as a system used by an organisation to fulfil
its legal tasks and responsibilities in relation to pharmacovigilance and designed to
monitor the safety of authorized medicinal products and detect any change to their
risk-benefit balance [DIR Art 1(28d)].
A pharmacovigilance system, like any system, is characterised by its structures,
processes and outcomes. For each specific pharmacovigilance process, including its
necessary structures, a dedicated Module is included in good pharmacovigilance
practices (GVP).

4. i3 Consult
Wider Meaning of Pharmacovigilance
 Apart from ethical drugs & OTCs, pharmacovigilance embraces any
treatment intervention
− Medical devices, vaccines, blood products, biological products e.g. mAbs,
traditional medicines, herbals, nutriceuticals and complimentary medicines
 Side Effects, Adverse Events, Side Effects & Drug-drug Interactions
− Medicines may affect the patient/individual in unintended ways, such effects
(side effects), even events/episodes (adverse events) may arise from multiple
drugs being taken (drug-drug interactions), all posing a clinical risk

5. i3 Consult
Pharmacovigilance Work Flow
Data
Acquisition
ADR
Clinical development
Observational &
Epidemiology
Preclinical
Detection
Statistical treatment
Data mining
Disproportionality &
Anomalies
Quantitative
Correlations
Assessment
Causality evaluation
Signal assessment
Benefit-Risk assessment
Risk management
Intervention
Dear Dr. Letters
RMPs
License renewals
Marketing
authorisation
annulments
Label & product insert
changes
Safety reports

6. i3 ConsultDevelopmentStage
Pre-clinical
Clinical studies – Phase I to IV
PostMarketing
Marketing Authorisation
Holders (MAH)
Voluntary Reporting
Data Analysis from MAH
Communication Media
PMS
Misuse or errors
E-monitoring of safety
Data Sources

7. i3 ConsultSignal Detection
 EMA & MAH both responsible for managing safety signals.
 Safety signal may arise from simply patient/individual has a preexisting medical
condition (other than the condition s/he is being treated for) or due to a drug-
drug interaction, i.e. an adverse event is NOT always a consequence of the drug
treatment.
 Safety signal management requires establishing whether there is a causal
relationship between the adverse event and the drug treatment.

8. i3 ConsultDetection Management
 Differentiate between a true signal having a causal relationship with the drug treatment
and that of background “noise” caused by media coverage or raised awareness due to
socio-political or geographical trends.
 Select suitable method of signal detection where there is collaboration between different
MAHs.
 Select detections of interests BUT provide a rationale for non-detections.
 Prioritise these signal detections.
 Standardise the signal evaluation so that reproducibility stems from different evaluators.
 Contraction of time delay between occurrence of AE until data is processed is KEY.
 Quality management system requires documentation in place, an audit trail & OJT
training.

9. i3 ConsultRisk Management
 Aims to maximise the margin of clinical benefit of the drug above the risk associated with
that product
 A Risk Management Plan (RMP) for the entire lifecycle of the drug must:
 Identify what is known and unknown about the product's safety
 Describe counter measures taken to minimise any risks associated with the product and
an evaluation made of these interventions
 Outline obligations conditional to marketing authorisation
 Outline additional PMS measures on efficacy, safety etc.

10. i3 ConsultRisk Reduction Strategies
 Choose the most amenable and effective risk reduction measure according to the
severity and critical nature of the identified risk
 Monitoring of specific sub-populations – expectant mothers, patients with underlying
chronic conditions and children
 Procedure stringency with patient ID ( DoB & addresses) and data protection laws (GDPR)
so that signal detection can be accurately cross referenced
 Make clear distinctions between RMP educational data and sales promotion data

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