Periodic Benefit-Risk Evaluation Report (PBRER / ICH E2C(R2))

Overview

Draft and validate the PBRER per ICH E2C(R2) for authorised medicinal products. Integrates cumulative safety and efficacy for EMA, FDA (PADER), and other authorities.

Example Conversation

You: We need to finalise the PBRER for our authorised product; DLP is 2025-06-30. Can you draft the missing sections and run the section validator?

Agent: I’ll ensure introduction and reference information (including DLP 2025-06-30), worldwide MA status, signal evaluation with conclusions, cumulative safety, benefit evaluation, benefit-risk analysis with a clear conclusion, and risk minimisation measures cross-referenced to the RMP. Then I’ll run pbrer_section_validator on the draft.

Agent: Updated pbrer-draft.md and ran pbrer_section_validator…

Agent: Check PASS — all key section types are present, DLP is stated, signal conclusions and benefit-risk conclusion are present, and RMP cross-reference for risk minimisation is included.

What the Tools Validate

The skill includes one extension tool:

pbrer_section_validator checks the PBRER against ICH E2C(R2) required sections:

• Mandatory section coverage — Introduction, reference information, worldwide MA status, signal evaluation, cumulative safety, benefit evaluation, benefit-risk analysis (and related content).
• Data lock point (DLP) — DLP must be stated with a valid date format.
• Signal evaluation — Signal section must include a conclusion per signal.
• Benefit-risk conclusion — A clear benefit-risk conclusion (integrated assessment) must be present.
• Risk minimisation — Risk minimisation measures must be cross-referenced from the risk management plan (RMP).

Output: PASS if all checks are satisfied; otherwise FAIL with a short line per missing element. Run on the draft before submission; fix gaps and re-run until the check passes.

Output Excerpt

Excerpt from a generated PBRER and sample validator report.

PBRER (excerpt):

## 1. Introduction and reference information
Product: [Name]. Active substance: [Name]. Data lock point (DLP): 2025-06-30. Authorised indications: [List]. Estimated exposure: [Summary].

## 5. Signal evaluation
[Signal 1]: Evaluation complete; no new safety concern. [Signal 2]: Ongoing; conclusion pending next cycle.

## 7. Benefit-risk analysis
Overall benefit-risk conclusion: The benefit-risk balance remains positive for the approved indications. Risk minimisation measures are as described in the RMP (Section X).

pbrer_section_validator report (excerpt):

=== PBRER SECTION VALIDATOR (ICH E2C(R2)) ===
Result: PASS

Document: pbrer-draft.md
PBRER section coverage: 7 key section types present.
Data lock point (DLP) is stated with date.
Signal section includes conclusions per signal.
Benefit-risk conclusion is present.
Risk minimisation measures are cross-referenced from RMP.
PBRER meets ICH E2C(R2) section and content expectations.

Getting Started

Add your source materials to the project workspace (safety data, efficacy data, RMP, signal list), then activate the Periodic Benefit-Risk Evaluation Report (PBRER / ICH E2C(R2)) skill. The agent will guide you through introduction, MA status, signal evaluation, cumulative safety, benefit-risk analysis, and running pbrer_section_validator before regulatory submission.