5. Drug Safety and Regulatory Affairs

Word

Example

pharmacovigilance

Pharmacovigilance ensures drug safety after market release

adverse event (AE)

Any adverse event must be reported immediately

serious adverse event (SAE)

A serious adverse event requires regulatory reporting

regulatory affairs

She specializes in regulatory affairs for new medicines

post-marketing surveillance

Post-marketing surveillance monitors long-term drug safety

black box warning

The drug has a black box warning for severe side effects

patient information leaflet (PIL)

The patient information leaflet explains dosage instructions

drug recall

A drug recall was issued due to contamination concerns

safety data

The safety data must be reviewed before drug approval

risk-benefit assessment

The risk-benefit assessment supported the drug's approval

regulatory submission

The regulatory submission process took six months

FDA approval

The medication received FDA approval last year

European Medicines Agency (EMA)

European Medicines Agency regulates drug approval in Europe

clinical trial report

The clinical trial report was submitted for review

counterfeit medicines

Counterfeit medicines pose a serious health risk

drug labeling

Drug labeling includes dosage and side effect warnings

reporting obligations

Companies have reporting obligations for adverse reactions

controlled substance

This is a controlled substance and requires a prescription

off-label use

Off-label use of this drug is not recommended

drug safety monitoring

Drug safety monitoring helps prevent harmful side effects