Regulatory Terms Starting With S

SAFETY SIGNAL

SAFETY SIGNAL is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

SAFETY Specification

SAFETY Specification guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Serious Adverse Event (SAE)

An adverse event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.

SHELF LIFE

SHELF LIFE supports cross-functional regulatory execution across quality, clinical, and safety teams.

Signal Detection

The process of identifying new or changing safety information from pharmacovigilance data that may require further investigation.

SIGNAL Management

SIGNAL Management guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Software AS A Medical DEVICE

Software AS A Medical DEVICE is used to support defensible premarket and postmarket device decisions.

SOURCE DATA Verification

SOURCE DATA Verification supports cross-functional regulatory execution across quality, clinical, and safety teams.

Special Controls

Special Controls helps teams standardize terminology and improve decision traceability.

Stability Testing (Stability)

Testing to determine how a drug product's quality changes over time under the influence of environmental factors.

Statistical Analysis PLAN

Statistical Analysis PLAN supports compliant clinical development and cleaner decision-making across trial phases.

Substantial Equivalence

Substantial Equivalence supports cross-functional regulatory execution across quality, clinical, and safety teams.

Surrogate Endpoint

Surrogate Endpoint is central to trial design quality, protocol execution, and evidence credibility.

SUSAR (SUSAR)

SUSAR is a safety governance concept used to detect, evaluate, and mitigate post-market risks.