Risk Management · Section 9.6
~5 min read · The Drug Safety Coach — Global PV Career Course
Key points
Full text
This lesson exists specifically because PAES and PASS are genuinely one of the most commonly confused pairs of acronyms in pharmacovigilance — they look similar, sound similar, and both live inside the RMP structure, which makes the confusion understandable even though the two concepts address fundamentally different questions.
A Post-Authorisation Efficacy Study (PAES) exists to resolve remaining uncertainty about how well the drug actually works — not whether it’s safe, but whether its benefit holds up as expected in a population, dosing scenario, or real-world context that wasn’t fully characterised at the time of approval. This is exactly why PAES gets its own dedicated Part IV in the RMP structure, distinct from every other part’s safety orientation, as Lesson 9.2 flagged explicitly.
A Post-Authorisation Safety Study (PASS), by contrast, exists to resolve remaining uncertainty about safety — investigating a specific identified or potential risk, or filling a missing-information gap the Safety Specification identified. Structurally, a PASS typically lives inside Part III, the Pharmacovigilance Plan, as exactly the kind of "additional PV activity" the previous lesson described, rather than getting its own dedicated RMP part the way PAES does.
The reliable way to keep the two straight, beyond memorising which part of the RMP each belongs to, is to ask a single question of any study you encounter: is this study trying to answer an efficacy question or a safety question? A study investigating whether a drug’s effectiveness holds up in elderly patients with reduced renal function is a PAES question. A study investigating whether a drug genuinely causes an elevated rate of a specific adverse event in real-world use is a PASS question. And it’s entirely normal for a single product to have both running at the same time, addressing genuinely separate open questions about the same product.
Important
PAES and PASS are two of the most frequently confused acronyms in pharmacovigilance, precisely because they look and sound so similar. The reliable test: PAES is about EFFICACY (does the drug work as well as needed, in a population or scenario still uncertain), and it sits in its own dedicated RMP Part IV. PASS is about SAFETY (is a specific risk what we think it is), and it sits inside the Pharmacovigilance Plan in Part III as an additional PV activity. Getting this backwards in an interview is a fast way to undermine an otherwise strong answer.
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. A regulator requires a company to run a study specifically investigating whether a drug’s effectiveness holds up in patients with severe renal impairment, a population underrepresented in the original trials. Is this a PAES or a PASS?