Panel · Use case · Pharmacovigilance

Risk-Minimization Measures.

LiveConsensus Delphi

Which additional risk-minimization measures are proportionate for the identified risk?

SetCandidate additional risk-minimization measures

SeatsSafety, medical, regulatory, medical information

ReaderSafety and regulatory leads

Not askedA risk management plan

DepthStandard, four seats

Risk-Minimization Measures is a ready-made use case for Pharmacovigilance. It ships under the Consensus Delphi template.

For drug safety leads. You get each seat's stance on every statement, where consensus holds, the residual disagreement and the consensus statement with its limits. 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

Which additional risk-minimization measures are proportionate for the identified risk?

Who rates

EMA separates routine measures, such as product information and pack size, from additional measures used when routine ones will not be enough. In the US, REMS elements can include certification, restricted dispensing and monitoring.

Seat	What it rates from	Why it is at the table
Head of Pharmacovigilance	Whether each measure addresses the risk and can be shown to work.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures.}	GVP Module XVI.
Global Medical Affairs Director	Whether each measure is proportionate to the harm and workable for clinicians.	Clinical practice.
Regulatory Strategist	Whether each measure is likely to be acceptable and how it is documented.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures.,2U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategies (REMS).}	GVP and FDA REMS.
Medical Information Services Master	Whether each measure can be communicated and answered at the enquiry line.	Enquiry practice.

What the run does

Proportionate is the test. Each measure is rated on whether it fits the size of the risk and the burden it places on patients and clinicians.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures.}

Effectiveness is part of the statement. A statement about a measure must say how its effectiveness would be known.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures.}

Access is a cost. The FDA page on REMS lists elements that can limit access. The seats rate the burden against the benefit of the measure.^{2U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategies (REMS).}

Recommended length

Standard

Four disciplines each rate every statement. Standard depth gives one round with seat counts and the residual disagreement in about four pages.

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

Assumptions the run makes

The run states the assumptions behind its statements and its rule, and says what each gap limits. Examples for this set:

The identified risk is correctly characterized.
Routine measures alone are not enough.
Clinicians will comply with additional measures.

Standards, guidance and sources

Frame

EMA, GVP Module XVI: Risk minimisation measures.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures.}
FDA, Risk Evaluation and Mitigation Strategies.^{2U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategies (REMS).}

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

What gets flagged

Any measure rated proportionate with no stated way to judge it, any measure that restricts access, and any split between safety and medical seats.

What arrives

The statements and the consensus rule
Verdict and status
Independent first pass, by seat
Agreement by statement
Movement after feedback
Residual disagreement and cruxes
What a real Delphi would add
The consensus statement and its limits

What it will not do

The agreement is a simulation by AI specialists and not a Delphi with real experts. The consensus rule is fixed before any result, and agreement is not correctness.

It does not decide the measures. That belongs to the safety committee and the regulator.

It is a simulation by AI specialists and not a Delphi with real experts. A small panel of three to five seats is below every panel size found in the literature, and the report says so.

It does not treat agreement as truth. Consensus is not correctness.

It does not change the rule after seeing the result.

References

[1] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures. Not read in full.
[2] U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategies (REMS). Read on 9 October 2026 at its earlier address.

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.