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

> Draft and validate the Periodic Benefit-Risk Evaluation Report per ICH E2C(R2). Integrates cumulative safety and efficacy data for an authorised medicinal product, producing a benefit-risk evaluation for regulatory submission to EMA, FDA (PADER), and other authorities.



Tags: ICH, PBRER, Pharmacovigilance, E2C(R2), Benefit-Risk, Regulatory, EMA, Drug Safety


## Example Prompts

- Draft the PBRER for our authorised product covering all 17 ICH E2C(R2) sections
- Validate our PBRER draft for mandatory sections, DLP, and benefit-risk conclusion before submission
- Prepare the cumulative safety data tabulations and signal evaluation for our periodic report

URL: https://rakenne.app/skills/ich-pbrer-pharmacovigilance/index.md

Try this skill: https://rakenne.app/a/?skill=ich-pbrer-pharmacovigilance


## 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):**

```markdown
## 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.


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