Panel · Use case · Pharmacovigilance

Safety Signal Divergence.

LiveDivergence Review

Map where specialists disagree on whether a safety signal warrants a label change, and what would settle it.

QuestionDoes the signal warrant a label change?

DisciplinesSafety, regulatory, evidence, medical information

ReaderSafety and regulatory leads

Not askedA regulatory submission

DepthStandard, four seats

Safety Signal Divergence is a ready-made use case for Pharmacovigilance. It ships under the Divergence Review template.

For pharmacovigilance leads. You get each seat's answer to the same question, where the positions diverge, whether each split is evidence, assumption or value, the cruxes and what would settle it. Claims are cited or marked as gaps.

Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.

The decision

Does a new safety signal from post-marketing reports warrant a label change?

Who is at the table

A signal is a hypothesis from reports. Whether it becomes a label change depends on the strength of the evidence and on what regulators have asked in similar cases.

Seat	What it is asked	What it works from
Head of Pharmacovigilance	How strong the signal is on case counts, disproportionality and clinical detail.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1.,2Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.}	Spontaneous reports and the signal management process.
Regulatory Strategist	What a label change would require and how the agency has acted on similar signals.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1.}	Agency practice and the product’s labeling.
Global Value & Evidence Lead	What other data would confirm or refute the signal: trials, cohorts, registries.	Published studies.
Medical Information Services Master	What prescribers are being told and asking, and how an interim communication would be handled.	Enquiry data and communication practice.

What the review does

A signal is not a risk. Reporting depends on who reports and what is already known. The review labels disproportionality results as signals and keeps them apart from rates.^{2Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.}

Evidence or value. Some seats will disagree about how much evidence is enough, which is a matter of evidence. Others will disagree about how to weigh a rare serious risk against a benefit, which is a matter of value. The review says which is which.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1.}

What would settle it. A named analysis, such as a cohort study or a case review, with the decision each result would inform.

Recommended length

Standard

Four disciplines will read this question differently. Standard depth types each divergence as evidence, assumption or value in about four pages.

You can pick another length on the form. The other two stay available.

Assumptions the review checks

The review states the assumptions each position relies on, and says what each gap limits. Examples for this question:

The reports are not duplicates and are not driven by publicity.
The event is not explained by the underlying disease.
The signal applies to the whole class and not to this product alone.

Standards, guidance and sources

Frame

EMA, GVP Module IX: Signal management (Rev. 1).^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1.}
Evans, Waller and Davis, proportional reporting ratios, 2001.^{2Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any rate computed from spontaneous reports, any seat that treats a signal as confirmed, and any confirmation that rests on the same reports.

What arrives

The question as put
The shape of the disagreement
Each position, in its own terms
Where they diverge
Why they diverge: evidence, assumption or value
The cruxes
What would settle it

What it will not do

It does not force a consensus, and it is a deliberation of AI specialists and not a vote of human experts. The decision stays with you.

It does not decide whether the signal is validated or whether a label change is needed. That decision belongs to the safety committee.

It does not force a consensus. A report that closes every gap would be the wrong output.

It is not a vote of human experts. Every seat is an AI specialist, and the report says so.

It does not name a winner. It says what would settle the question and leaves the decision to you.

References

[1] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Scope as given in EMA’s listing; not read in full.
[2] Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486. Abstract only.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

About the Panel service

Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.

To edit a saved template, open New → Panel → From template, or the library rail on the service form.