In this short piece I’ll step into the signatory seat and explain what risk assessment actually looks like when I review a job bag: not a sterile tick-box exercise, but a live weighing of audience, context, evidence and consequence.
The real moment of sign-off
There’s a quiet second before I click certify. One PDF on screen, a thin evidence pack, and a marketing team waiting. As a final medical signatory, I’m not “doing a checklist”. I’m deciding what I can defend—because signatory personal liability is real, and Clause 8 of the ABPI Code ties my name to the certification and examination record.
What people think signatories do vs what we actually do
They think: tick claims, tick references, approve.
We actually do: run the material through reality—audience perception, context of use, product maturity, indication scope, channel (promo vs non-promo vs social), and the cumulative impact of the whole campaign.
Why checklists alone fail
A “low risk” line in an HCP email can become “high risk” when it’s screenshot on social. A balanced claim in isolation can mislead when paired with a bold headline elsewhere in the job bag. Risk moves.
“Signing off is not a rubber stamp — it's a moment to record why we've chosen an acceptable balance of risk and benefit.” — Dr. Anzal Qurbain
AskAnzal helps teams learn that risk isn’t eliminated; it’s understood, justified, and managed—so compliant communication stays confident.
Risk assessment isn't a checklist
People assume ABPI Final Signatory work is a checklist: tick the abpi code of practice boxes and approve. From my seat, sign-off is rarely black or white. I’m weighing risk management and compliance in the real world: audience perception, context of use, product maturity and evidence base, indication scope, channel (promotional vs non-promotional vs social/digital), and the cumulative impact of promotional materials and activities. The ABPI Code is perception-based: it’s about what people take away, not what we meant.
What people think signatories do vs what we actually do
They think: “Is every claim referenced?”
We actually do: “What will a busy HCP infer, and what happens when this sits next to the last three assets?”
Why checklists alone fail
Checklists are memory aids, not decision engines. A “balanced” efficacy line can be low risk in an SPC-linked email to specialists, but high risk on a social tile where the visual shouts benefit and the safety sits in a footnote. “Low risk” and “high risk” move with audience, format, and timing.
A checklist gets you to the door; judgement decides whether you stay in the room.
My practical test: simulate the reader reaction—who is this for, what do they already believe, and what could they infer wrongly? Good signatories don’t avoid risk; we document, justify, and manage it—so teams can communicate with confidence. On my mentorship programme this is one of the fundamentals that i try to cover.
What people think signatories do vs what we actually do
When I review a job bag as an ABPI Final Signatory, people often expect a quick tick-box “risk assessment”. In the modern signatory role, it’s closer to scenario planning: how will this land, where will it travel, and what happens when it sits next to everything else we’ve already approved?
What people think signatories do vs what we actually do
Myth: We’re gatekeepers who say no.
Reality: We advise, balance risk, and enable confident communication—especially across medical and non-medical signatories working as one system.Myth: We only check facts.
Reality: We test audience perception, context of use, indication scope, product maturity, and channel (promotional vs non-promotional vs social/digital).Myth: Sign-off is binary.
Reality: It’s often a documented compromise: “yes, if we add a qualifier, tighten the claim, and align the PI link.”
Why checklists alone fail
A banner claim can be “low risk” in isolation, then become “high risk” when reused in a paid social carousel, or when three similar pieces create cumulative impact. Under the single-signatory model, the medical signatory carries ultimate responsibility—so signatory decision-making leans on judgement, experience, and records (PMCPA expectations), not risk avoidance.
Our job is to make marketing safe and effective — not to frustrate great ideas. We say 'how', not just 'no'.
Risk isn’t something I eliminate; it’s something I understand, justify, and manage—often with AskAnzal-style mentoring to navigate the grey with confidence.
Why checklists alone fail
What people think signatories do vs what we actually do
They think: I tick boxes in the review and approval process and stamp “approved”.
We actually do: I picture the real audience, the real channel, and the real campaign footprint—then decide what can be justified and managed.
Why checklists alone fail
Checklists are useful, but they don’t see context. A claim can look “fine” until you place it next to an image, a headline, or a footnote that changes the meaning. In promotional materials and activities, that surrounding framing is often where risk lives.
Digital makes this sharper. Short copy can carry big claims once it’s shared, cropped, or boosted. I’ve seen a “compliant” social carousel where each slide passed pre-vetting of materials, but together they implied an unapproved indication.
And checklists don’t catch cumulative impact across assets. That’s why campaign-level governance matters—ABPI’s Working Together guidance (May 2022) pushes clear ownership and re-certification when content changes. It also matters as AQPs expand (2023–2024): equivalent training and validation are non-negotiable, or certification drifts.
A colleague stated: "I've signed off materials where every checklist item passed — and still had to flag the campaign risk."
Risk isn’t something I eliminate; it’s something I understand, document, and manage—so teams can communicate with confidence, not fear, with AskAnzal-style mentoring when the grey areas bite.
What i'm juggling: the real-time considerations
When I review job bags as an ABPI Final Signatory, “risk assessment” isn’t a checklist. It’s governance and risk management in motion—balancing evidence, audience and channel, because no single rule fits all (PMCPA 2024).
What people think signatories do vs what we actually do
Think: tick boxes, say yes/no.
Actually: predict how promotional materials and activities land in real life, then document a defensible rationale as an appropriately qualified person.
Why checklists alone fail
A checklist can’t see cumulative impact. Five “small” claims across email, booth panels and a rep leave-behind can add up to a big implied promise. “Low risk” becomes “high risk” once repetition and context kick in.
In my head, I’m scoring:
Audience perception: HCPs, patients, payers infer differently—I map likely takeaways.
Context of use: a congress slide vs a social post changes the risk calculus.
Product maturity: strong peer-reviewed evidence helps, but doesn’t remove judgement.
Indication scope + channel: promotional vs non-promotional vs digital needs different thresholds.
Isolation vs reality: a mock-up is fine; in-situ layout may over-emphasise.
Audience and channel are the twin lenses through which risk must be viewed."
Most of my feedback is mitigation—wording, references, prominence—so teams can communicate confidently.
Job-bag scenarios i actually see
What people think signatories do vs what we actually do
They think: tick boxes, say “no,” avoid a breach of the ABPI Code.
We actually do: weigh audience perception, context of use, product maturity, indication scope, channel, and cumulative impact—then document why.
Why checklists alone fail
A checklist can’t tell me how a claim lands in the real world, or how it looks next to last month’s assets. “Low risk” shifts fast—especially once the complaints process ABPI starts asking what we knew, when, and what we recorded. Robust job review notes matter more than ever.
Scenario A — mature product, incremental claim
Strong data, but the image implies superiority. I’ll approve with a small wording change, swap the visual, and add a clear rationale in the job bag.
Scenario B — cumulative campaign risk
Each piece is “fine,” together they imply broader claims. I mitigate at campaign level and do consolidated sign-off.
Poor judgement can mean withdrawal, audits, financial penalties, even public reprimand. My job is judgement-led compliance—so marketers can communicate confidently. AskAnzal helps teams navigate the grey with calm, usable documentation.
How experienced signatories actually think
When I review a job bag as an ABPI Final Signatory, “risk assessment” isn’t a checklist. It’s signatory decision-making under real-world pressure: what will the audience infer, in this channel, today?
Why checklists alone fail
I build a short, defensible narrative: claim, evidence strength, likely audience inference, mitigations, then final judgement. A checklist can’t tell me how a “balanced” claim lands on social, or how a footnote reads on a busy slide.
What people think signatories do vs what we actually do
They think: tick boxes, say “no”, avoid risk.
We do: manage risk with proportionate controls, document why, and enable confident use.
Example: Cumulative impact changes the risk - a mature product with a strong evidence base can support stronger wording than a new indication with limited data. “Low risk” and “high risk” move with context.
Good signatories create defensible outcomes; they don't win by saying 'no' more often than others."
That’s why signatory skills training and training and mentorship matter: pattern recognition, succinct rationales, and governance (AQPs/committees) reduce blind spots. AskAnzal helps teams practise this judgement-led compliance—so creativity isn’t blocked, it’s made defensible.
Practical reframing: understand, justify, manage
From the signatory’s seat, risk-based decision making isn’t a tick-box. It’s a live judgement call shaped by audience perception, context of use, product maturity, indication scope, channel (promo vs non-promo vs social), and the cumulative impact of what’s already in market. A claim can look fine in isolation, then tip into “high risk” when it’s the fifth similar asset in a campaign.
What people think signatories do vs what we actually do
They think: apply internal standard operating procedures and say yes/no.
We actually: weigh grey areas, document why, and protect confident communication.
Why checklists alone fail
A ten-step SOP can’t capture reality: a “patient-friendly” infographic reused by reps, or a disease-awareness post that becomes promotional once comments and links appear. Risk categories aren’t static; they move with evidence gaps, channel behaviour, and campaign exposure.
The best outcomes happen when risk is described, not dismissed."
Governance and oversight: understand, justify, manage
Understand: map audience, channel, evidence base, and cumulative exposures.
Justify: add a short job-bag rationale explaining why the decision is proportionate—defensible under PMCPA review. ABPI Working Together and Clause 8 both push record-keeping and governance and oversight.
Manage: use proportionate mitigations (wording, prominence, staging, pre-vetting) and record variations and final materials.
Closing: judgement-led compliance and reassurance
What people think signatories do vs what we actually do
People think the final medical signatory runs a checklist and says yes/no. In reality, I’m weighing how a claim lands with the audience, the context of use, product maturity and evidence base, indication scope, channel (promo vs non‑promo vs social), and the cumulative impact of a whole campaign. A banner might look fine alone, but risky beside a sales aid and a “reminder” email.
Why checklists alone fail
Risk isn’t static. The same line can be low risk in a congress booth and higher risk on LinkedIn. “Low” and “high” shift with wording, prominence, balance, and what else is in the job bag. That’s why I lean on judgement, experience, and documentation: decisions should be defensible, documented, and proportionate to the risk, aligned to working together guidance as it evolved from 2021–2025.
I’ve rarely found “no” is the only outcome. More often it’s “how”: tighten the claim, add context, adjust layout, or change channel so we can communicate confidently without pretending risk can be eliminated.
Anzal Qurbain "Judgement-led compliance helps marketing and medical teams succeed together — that's the goal I sign up to every time."
If you want signatory mentorship that turns checklists into clear rationales, follow AskAnzal for realistic ABPI insight, templates, and training pointers—so creativity ships safely, not silently.
TL;DR: Risk assessment is judgement-led, context-driven and documented. Good signatories enable confident communication by understanding, justifying and managing risk — not by hiding behind checklists.