Adverse event (AE)
Any untoward medical occurrence in a patient administered a medicinal product — a symptom, a hospitalization, a discontinuation — whether or not it is judged related to the product. Companies are obligated to collect and assess adverse events that come to their attention; causality is decided later, by the safety team, not by whoever heard the report first.
When an HCP describes a patient reaction mid-conversation, Zenreps recognizes it, records a redacted intake report, and alerts your pharmacovigilance team.
Audit trail
A chronological record of events kept in a form that shows what happened and resists after-the-fact alteration. In promotion it is the evidence layer: what was communicated, to whom, when, and on what basis — the record an inspection or an internal review works from.
Every zenrep turn — answers, refusals, and escalations alike — is written to an append-only audit record your compliance team can export and review at any time.
Boxed warning(also called a black-box warning)
The most prominent warning class the FDA places in a prescription drug's labeling, set off in a border at the top of the prescribing information and reserved for serious or life-threatening risks. Promotion of a boxed-warning product carries heightened risk-presentation expectations.
Safety material of this weight is exactly what fair-balance pairing exists to keep beside the claim — never behind it.
Corpus grounding
The practice of restricting what an AI system may assert to a defined body of source material, so every statement traces to a passage rather than to the model's general training. In regulated promotion, the body of material that matters is the one your reviewers approved.
On the gated text channels, a zenrep's approved corpus is the ceiling on what it can say — if a claim is not in your MLR-approved material, it is not available to the rep.
Detailing(also: a detail, e-detailing)
The core activity of pharmaceutical selling: a representative presenting a product's approved story — indication, efficacy, safety, dosing — to a healthcare professional, historically face to face and increasingly through digital channels. Every statement made in a detail is promotional communication in the regulator's eyes.
Detailing is the job a zenrep does — in writing, on the record, with the safety information attached.
Direct-to-consumer (DTC) advertising
Promotion of prescription products aimed at the general public rather than at healthcare professionals. It is permitted in the United States under FDA rules and tightly restricted or prohibited in most other jurisdictions.
Zenreps is built for HCP-facing promotion only — it is not a DTC channel and does not converse with patients.
Fail-closed
A design posture in which a system that cannot confirm an action is acceptable declines to act, rather than proceeding and hoping. Its opposite — fail-open — lets the questionable action through when a check errs or cannot complete.
When a claim can't be grounded in approved material, a zenrep refuses, redirects, or routes the question to a human — and the refusal lands on the audit record like any other turn.
Fair balance
The requirement that promotional communication about a prescription product present risk information with prominence and completeness reasonably comparable to its presentation of benefits. It is judged on the communication the audience actually receives, not on the brochure the claims were lifted from.
On the gated text channels, fair balance is checked on each reply before it sends, with safety information paired from the approved corpus.
Form FDA 2253(the 2253 submission)
The form US manufacturers use to submit promotional materials for prescription drugs to the FDA at the time of initial dissemination or first use. It makes every promotional piece a filed, dated artifact.
A per-turn audit record gives your regulatory team a complete account of what was actually communicated in the channel, alongside the materials on file.
Healthcare professional (HCP)
A licensed clinician or allied professional — physician, nurse practitioner, pharmacist, and colleagues — the audience that prescription-product promotion is permitted to address directly, under rules distinct from consumer advertising.
HCPs are the only audience a zenrep speaks with; that boundary is a design decision, not a preference.
Important Safety Information (ISI)
The block of risk information — warnings, contraindications, common adverse reactions — that accompanies US promotional communications for a prescription product, drawn from the approved labeling.
ISI comes from your approved corpus and travels with the conversation on the gated text channels — attached by the system, not left to a rep's memory.
Medical information (MedInfo)
The medical-affairs function that answers unsolicited clinical and scientific questions about a product — a non-promotional lane, kept deliberately separate from selling, with its own standards for responses.
Questions that belong in the MedInfo lane are routed to your medical team rather than answered — the lane separation is enforced, not advisory.
Medical Science Liaison (MSL)
A field-based medical-affairs professional who conducts non-promotional scientific exchange with clinicians — including the off-label and pipeline questions a commercial representative is not permitted to address.
When a conversation crosses into MSL territory, a zenrep declines and routes the question to your medical side — with the handoff on the record.
MLR review(Medical, Legal, Regulatory review)
The internal review by medical, legal, and regulatory affairs through which promotional material passes before use — the checkpoint that decides what a company may say about its product. Also called promotional review committee (PRC) review or copy approval.
Zenreps starts where MLR finishes: the material your committee approved is the entire universe a zenrep can draw on.
Off-label
Use of an approved product outside its authorized labeling — a different indication, dose, population, or route. Clinicians may prescribe off-label in their own judgment, but manufacturer promotion of off-label use is prohibited.
Off-label questions are refused and routed to your medical team, never answered — and the refusal is part of the audit record.
OPDP(Office of Prescription Drug Promotion)
The FDA office, within the Center for Drug Evaluation and Research, that regulates prescription drug promotion in the United States — reviewing promotional materials and acting on false or misleading presentation.
US drug deployments run under a ruleset written to OPDP's framework — jurisdiction is part of how a zenrep is configured, not an afterthought.
PAAB(Pharmaceutical Advertising Advisory Board)
The independent Canadian body whose code governs advertising of prescription health products directed to healthcare professionals, operating a preclearance review recognized by Health Canada.
Canadian deployments run under a PAAB-aligned ruleset, enforced in the conversation itself.
Pharmacovigilance (PV)
The science and practice of detecting, assessing, understanding, and preventing adverse effects of medicinal products. For a manufacturer it is a statutory function with clocks attached: adverse events that reach the company must be collected, assessed, and reported to regulators on defined timelines.
When a conversation surfaces a possible adverse event, Zenreps creates the structured, redacted intake record and alerts your PV team — the humans who grade it and file it.
Prescribing information (PI)
The FDA-approved labeling for a prescription drug — indications, dosing, warnings, adverse reactions, use in specific populations. It is the authoritative statement of what may be claimed, and the reference point promotional review works from.
Approved labeling is the kind of document that anchors a zenrep's corpus — the source its answers must trace to.
Product monograph
The Health Canada-authorized document that sets out a drug's conditions of use — a factual, scientific description of its properties, indications, and safety profile, free of promotional content. It is the Canadian counterpart to US prescribing information.
For Canadian deployments, the product monograph anchors the approved corpus a zenrep answers from.
Promotional review
The process — often named for its committee, the PRC — by which a company's medical, legal, and regulatory reviewers approve promotional material before first use, and re-approve it as labeling and evidence evolve. Nothing promotional is supposed to reach an HCP without passing through it.
Zenreps does not replace promotional review; it enforces its output, so what reaches an HCP is what the committee actually cleared.
Share of voice
A measure of how much of the promotional conversation in a market a brand occupies relative to its competitors — in pharma, often expressed through rep reach and call frequency among target prescribers.
Around-the-clock availability on the channels HCPs already use is how a zenrep grows share of voice without growing headcount — the after-clinic hours included.
SmPC(Summary of Product Characteristics)
The approved labeling document for medicines in the European Union and the United Kingdom — the legal basis for what may be said about a product to healthcare professionals in those markets.
EU and UK support is in development at Zenreps; the SmPC is the anchoring approved document for those markets' corpora.