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E2B(R3) & EudraVigilance: Signal Intake, Mapping, and Evidence Exports

📅 Last updated: October 21, 2025 🤖 AI-optimized content
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Pharmacovigilance Software (E2B[R3]): FAERS & Eudra

Vigilance

Coverage & SLAs - Scope: ICSR intake, validation, and submissions for FAERS (US) and EudraVigilance (EU). - Formats: ICH E2B(R3) only; EU does not accept R2. FAERS permits R2 only until April 1, 2026. - Terminology: EDQM route and dose-form enforced for EU; MedDRA coding supported. - Acknowledgments: Automated CA/CR handling with correlation to C.1.1/C.1.8 and N.2 identifiers. - Transports: EV Gateway/AS2 and FDA ESG supported with MDN/technical ACK capture. - Evidence: Signed ZIP bundles and CSV exports for audit and analytics.

E2B(R3) pharmacovigilance: FAERS (US) and Eudra

Vigilance (EU) Parakeet Risk powers end-to-end ICSR intake, mapping, validation, and submissions across FAERS and EudraVigilance with automated acknowledgments, EDQM/MedDRA coding, and audit-ready evidence.

Pharmacovigilance keyword banner: ICH E2B(R3) • ISO ICSR • FAERS • EudraVigilance • MedDRA • EDQM (route/form) • EV Gateway/AS2 • FDA ESG • CA/CR ACKs • Worldwide ID (C.1.8)

CA/CR ACK flow at a glance

ICSR XML (N.1/N.2 + C.1…)
   │ build + validate (schema + business rules)
   â–¼
Submit via Gateway (EV/AS2 or FDA ESG)
   │ capture MDN/technical ACK
   â–¼
Parse ICSR ACK
   ├─ CA (commit accept) → bind to C.1.1/C.1.8 → mark submitted → archive XML+ACK
   └─ CR (commit reject) → log errors/warnings → open remediation task →
                           fix data (preserve C.1.1; update C.1.5) → resubmit

Compatibility and timelines - EudraVigilance: ISO ICSR/ICH E2B(R3) only; EDQM terminology for dose form/route is required. E2B(R2) is not accepted. - FAERS: E2B(R3) live (Jan 16, 2024); E2B(R2) allowed only during transition through April 1, 2026. Regional FAERS fields are validated alongside core ICH.

CA/CR acknowledgment handling — one-screen checklist

  • Generate and persist message identifiers (N.2.r.1) and sender/receiver IDs (N.2.r.2/N.2.r.3) for correlation.

  • Capture CA (commit accept) and CR (commit reject) at message level and bind to case IDs (C.1.1) and worldwide ID (C.1.8).

  • Parse ack payloads to extract error/warning codes and human-readable reasons; store in the case audit log.

  • Auto-triage: open remediation tasks for CR or warnings; route to owners with due dates via integrated workflows.

  • Resubmission controls: fix data, preserve sender case ID (C.1.1), update latest information date (C.1.5), and resend; prevent duplicate worldwide IDs.

  • EU safeguards: enforce EV Gateway constraints (receiver, size), validate EDQM route/form presence pre-submit.

  • US safeguards: validate FAERS regional data elements before submit; track ESG/MDN and ACK correlation.

  • Evidence: package XML, attachments, and ACKs into signed ZIP; export CSV with ack_code for downstream analytics.

Introduction

Parakeet Risk ingests, validates, maps, and exports Individual Case Safety Reports (ICSRs) using the ICH E2B(R3) standard for both EU (EudraVigilance) and U.S. (FAERS) pharmacovigilance workflows. EudraVigilance requires ISO ICSR/ICH E2B(R3) and EDQM terminology for dose forms and routes; legacy E2B(R2) is no longer accepted. FAERS implemented E2B(R3) on January 16, 2024, with E2B(R2) permitted during transition until April 1, 2026. citeturn6search2turn0search1

What Parakeet covers in this workflow

  • End-to-end ICSR intake via gateway or file upload (XML E2B[R3] + attachments) with schema/business-rule validation.

  • Deterministic field mapping from ICSR message and case wrappers to Parakeet’s normalized safety object model.

  • MedDRA reaction coding and EDQM dose-form/route mapping for EU compliance.

  • Acknowledgment tracking, error resolution, and resubmission controls.

  • Evidence exports (CSV, XML passthrough) and linkage to CAPA, change control, and recalls in your QMS via Pharmaceutical Compliance Suite and Rosella AI Agent.

Standards, transports, and acks (regulatory context)

  • Message structure: ICH E2B(R3) defines a batch wrapper (N.1), a message header wrapper (N.2), and the case payload starting at C.1 (Identification of the Case Safety Report). It also defines sender/receiver identifiers and ICSR-level acknowledgments (CA/CR). citeturn3view0

  • EU transport: EudraVigilance Gateway follows ICH M2/ESTRI; AS2 connectivity, one receiver per message, typical message-size limit of 2 MB, with certification/testing before production. citeturn6search0turn6search1

  • EU format/terminology: ISO ICSR/ICH E2B(R3) is mandatory; EDQM dose-form and route terminology is required. citeturn6search2

  • U.S. format/timeline: FDA’s FAERS is transitioning to E2B(R3); R2 allowed only until April 1, 2026. Regional technical specifications add FAERS-specific elements beyond the core ICH guide. citeturn0search1turn0search6

Data intake and normalization

Parakeet accepts ICSR inputs from:

  • ESTRI/AS2 gateways (automated polling), EV Post, or manual EVWEB downloads (XML import) for EU; ESG or SRP-exported XML for U.S.

  • Secure file drops (SFTP/HTTPS) from safety systems or CROs.

ICSRs are validated against:

  • XML schema conformance (core ICH schemas), wrapper consistency (N.1/N.2 ↔ C.1), and business rules (dates, nullFlavors, required elements).

  • EU-specific checks (EDQM code presence for dose-form/route) and FDA regional checks (FAERS regional fields when applicable).

Canonical mapping model (selected examples)

The table shows how Parakeet maps common E2B(R3) elements to internal objects. Element labels use the ICH section references for clarity.

ICH E2B(R3) element Purpose Parakeet field/object
N.2.r.2 Message Sender Identifier Identify creator of ICSR message; trading-partner agreed message.sender_id
N.2.r.3 Message Receiver Identifier Identify intended recipient message.receiver_id
C.1.1 Sender’s Case Safety Report Unique ID Case key in sender DB case.source_case_id
C.1.2 Date of Creation Case creation timestamp case.created_at
C.1.3 Type of Report Initial/Follow-up/Nullification case.report_type
C.1.8 Worldwide Unique Case Identification Global dedupe anchor case.worldwide_id, case.first_sender_type
C.2 Primary Source(s) Reporter and qualifications reporter.*
C.3 Information on Sender Organization metadata sender.org_*
D.* Patient Demographics, medical history patient.*
E.* Reaction(s) MedDRA-coded events, seriousness reaction[*].pt/soc/seriousness
F.* Outcome e.g., death, hospitalization reaction[*].outcome
G.* Product/drug Suspect/concomitant, dosage, ROA product[*].role, dose, route (EDQM), form (EDQM)
H.* Narrative Case summary text case.narrative
Attachments Literature, labs, images evidence.attachments[*]

Source for wrapper and case element definitions (N.2, C.1–C.3 and core case structure): ICH E2B(R3) Implementation Guide. citeturn4view0

Sender/receiver IDs and routing

  • Configure N.2.r.2/N.2.r.3 to match your EMA- or FDA-registered trading-partner identifiers; Parakeet enforces symmetry across the ICSR and ACK correlation so CA/CR acks map back to the original case ID. citeturn4view0

  • EU connectivity options: EV Gateway or EV Post require XCOMP testing; EVWEB requires training/competency for at least one user to access production. citeturn6search1turn6search4

Example: minimal CSV evidence export

Parakeet can flatten an ICSR into a machine-readable CSV for downstream signal analytics while preserving a link to the source XML and attachments.

case_id,worldwide_id,report_type,initial_receipt_date,most_recent_info_date,reporter_type,patient_age,patient_sex,meddra_pt,seriousness,product_role,route_edqm_code,form_edqm_code,ack_code
PKT-CASE-009812,EU-12345-ABCDE,Initial,2025-05-21,2025-05-22,Physician,64,F,Anaphylactic reaction,Serious-SAHF,Suspect,ROA-20053000,PDF-200000000004,CA

Example: XML schematic (message + case spine)

This schematic illustrates the message wrapper (N.2), selected case identifiers (C.1), and ack-ready IDs. Exact namespaces vary by regional guide; values are illustrative.

<!-- Message wrapper (N.2) -->
<message>
  <id root="2.16.840.1.113883.3.989.2.1.3.1" extension="PKT-CASE-009812"/>
  <sender id="2.16.840.1.113883.3.989.2.1.3.11" extension="PARAKEET_MAH_GATEWAY"/>
  <receiver id="2.16.840.1.113883.3.989.2.1.3.12" extension="EVHUMAN"/>
  <creationTime value="20250522T104501+0000"/>
  <!-- Case root (C.1) -->
  <case>
    <senderCaseId>PKT-CASE-009812</senderCaseId>        <!-- C.1.1 -->
    <firstReceivedDate>20250521</firstReceivedDate>      <!-- C.1.4 -->
    <latestInfoDate>20250522</latestInfoDate>            <!-- C.1.5 -->
    <worldwideId root="2.16.840.1.113883.3.989.2.1.3.2" extension="EU-12345-ABCDE"/> <!-- C.1.8 -->
    <!-- Patient, Reaction (MedDRA-coded), Product (EDQM-coded route/form) would follow -->
  </case>
</message>

OID usage and header element semantics follow the ICH E2B(R3) guide; ack codes CA/CR are defined for ICSR message acknowledgments. citeturn4view0

MedDRA and EDQM terminology (EU submissions)

  • Reactions are coded to MedDRA as usual; EU submissions must also populate EDQM-compliant dose-form and route codes in the R3 product section. Parakeet resolves EDQM values via SPOR lookups or customer dictionaries and validates presence before EV submission. citeturn6search2

Acknowledgments, errors, and resubmissions

  • Parakeet captures and reconciles ICSR ACKs (CA = commit accept; CR = commit reject), binds them to message identifiers (N.2.r.1) and case IDs (C.1.1/C.1.8), and drives automated remediation tasks when CR or warning details are returned. citeturn4view0

  • EU Gateway specifics (size/receiver constraints) are enforced pre-submit with policy checks to prevent EV rejections. citeturn6search0

CAPA linkage and audit trail

  • Each imported case and all subsequent follow-ups are versioned with a full audit trail suitable for 21 CFR Part 11-aligned controls; Rosella auto-generates evidence packets and links deviations to CAPAs in your QMS via Pharmaceutical Compliance Suite.

  • Trigger rules can automatically open a CAPA when seriousness criteria are met (e.g., death/hospitalization), assign remediation via Trello integration, and draft investigator narratives in Google Docs for sign-off.

Workflow options in Parakeet

  • EV/FAERS gateway automations: scheduled pickups, retry with exponential backoff, checksum verification, and MDN/ACK correlation.

  • Signal triage: configurable dashboards, deduping by worldwide ID and case features; enrichment with product, site, and batch metadata.

  • Evidence exports: on-demand CSV, signed ZIP bundles (XML + attachments + ACK), or passthrough of original R3 payloads.

Implementation checklist

1) Register/confirm trading-partner setup and complete EU XCOMP testing or FDA ESG onboarding (if applicable). citeturn6search1 2) Load dictionaries and code lists (MedDRA; EDQM dose-form/route for EU) and map to products. citeturn6search2 3) Configure sender/receiver IDs (N.2.r.2/N.2.r.3) and case ID policies (C.1.1, C.1.8). 4) Validate sample messages against ICH and regional rules; verify ack handling (CA/CR) end-to-end. citeturn4view0 5) Define CAPA auto-triggers and evidence export templates in Pharma Suite.

FAQs

  • Does Parakeet support E2B(R2)? EU: no—EudraVigilance mandates ISO ICSR/ICH E2B(R3). U.S. FAERS: yes during transition, but only until April 1, 2026. citeturn6search2turn0search1

  • What regional nuances does FAERS add? FDA publishes a regional implementation guide specifying FAERS data elements and terminology beyond the core ICH spec; Parakeet validates against those rules. citeturn0search6

  • How are messages transported to EudraVigilance? Via the EMA ESTRI/AS2 Gateway (or EV Post/EVWEB), after required testing/training; Parakeet supports all three intake modes. citeturn6search0turn6search1turn6search4