{
  "node_id": "ich-e2e-pharmacovigilance-planning-2004",
  "title": "ICH E2E - Pharmacovigilance Planning: Safety Specification and Pharmacovigilance Plan (2004)",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2004-11-18",
  "bluf": "ICH E2E (Step 4, November 2004) requires a Safety Specification and Pharmacovigilance Plan to be submitted with marketing authorisation applications, defining…",
  "paywall": {
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    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
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  "crosswalks": {
    "_available_keys": [
      "eu_ai_act",
      "nist_csf",
      "iso_standard",
      "industry_mapping"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "ema-gvp-module-v-risk-management-systems-2014",
    "fda-21-cfr-part-312-ind-investigational-new-drug"
  ],
  "primary_citations_count": 6,
  "workflow_steps_count": 9,
  "schema_fields_count": 19,
  "citation_preview": [
    {
      "title": "ICH E2E - Pharmacovigilance Planning (Step 4, November 2004)",
      "url": "https://www.ich.org/products/guidelines/efficacy/article/e2e.html",
      "instrument": "ICH E2E",
      "jurisdiction": "International"
    },
    {
      "title": "ICH E2C(R2) - Periodic Benefit-Risk Evaluation Report (PBRER) (2012)",
      "url": "https://www.ich.org/products/guidelines/efficacy/article/e2c.html",
      "instrument": "ICH E2C(R2)",
      "jurisdiction": "International"
    }
  ]
}