Competency information
Details
Write up the findings of the risk assessment as a formal report and present the findings to an internal meeting, including an action plan.
Considerations
- Purpose of pharmacovigilance risk assessment.
- Committee for Medicinal Products for Human Use.
- Detection, assessment, minimisation and communication relating to the risk of adverse reactions.
- Therapeutic effect of the medicinal product.
- The design and evaluation of post-authorisation safety studies.
- How to perform pharmacovigilance risk assessment and audit:
- risk identification
- risk measurement
- analysis and evaluation (risk benefit evaluation)
- risk management
- monitoring the effect of risk management.
- Correct level of approval/authorisation.
- Monitoring clinical outcomes, positive and adverse drug reactions (ADR).
- Reporting any adverse drug reactions.
- Summary of product characteristics (SmPC), including likely frequency and severity of adverse drug reactions.
- Reporting mechanisms within and beyond your organisation.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 | Outcome Perform pharmacovigilance risk assessments. |