01 OS MedDRAとは201103（final）.ppt [互換モード]

1 12 meddra /J . meddra meddra /J . 2011 20 .. JMO . meddra /J 1 meddra /J 2. Copyright (c) 2011 JMO Copyright (c) 2011 JMO.. meddra . 10028257.. Mumps Mumps .. Oreillons meddra /J . Parotite epidemica . meddra /J 3 meddra /J 4. Copyright (c) 2011 JMO Copyright (c) 2011 JMO.. FDA . FDA . specificity, granularity .. WHOART JART MEDIS . COSTART ICD9 ICD9CM . HART .. meddra /J 5 meddra /J 6. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 1. meddra meddra . 1990 . ICH meddra . ICH M1 . ICH Medical Dictionary for Regulatory Activities ICH . ICH . MSSO/JMO.

2 meddra ) M dDRA/J. meddra /J .. Medical Dictionary for Regulatory Activities/Japanese . meddra . version ICH EU International Conference on Harmonisation meddra Terminology bundled with Japanese Translation . of Technical Requirements for Registration of Pharmaceuticals for Human Use . ICH PMDA ICH . ICH meddra /J 7 meddra /J 8. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra . meddra meddra . Standaidisd meddra Queries (SMQ). 84 26.. System Organ Class (SOC).. 335. High Level Group Term (HLGT).. 1,710. High Level Term (HLT). biopharmaceutical industry 19,086.

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5 MB . Change Request meddra . meddra . MSSO/JMO . MSSO meddra CTCAE .. BRP Blue Ribbon Panel) meddra . MB MSSO . External Expert Panel meddra . MSSO . Blue Ribbon Panel Meeting MB MSSO . meddra MSSO EU . HLT HLGT meddra . JMO . meddra /J 19 meddra /J 20. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. Change Request . meddra .. PT/LLT . LLT-PT PT-HLT . HLT HLGT meddra . SMQ / / SMQ .. MSSO . meddra .. meddra /J 21 meddra /J 22. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra ICH E2B . ICSR Individual Case Safety Report .. ICH .. E2B .. ICH E2B B1.

6 B2 . B3 . B4 . B5 . meddra /J 23 meddra /J 24. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 4. E2B meddra meddra /J .. meddra .. ( . LLT) . PT).. meddra PT LLT PT . meddra . E2B R3 2004 1999 12 . meddra /J 25 meddra /J 26. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 16 3 . 15 10 . meddra ICH E2B/M2 . meddra .. 90% .. meddra 100% . meddra . meddra /J 27 meddra /J 28. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra . meddra . EU EU +8 .. ICSR EMA EudraVigilance EVCTM EVPM). (E2B/M2) meddra . Volume9A (Pharmacovigilance). 90% . meddra Volume10 (Clinical trials.

7 EU-RMP (Risk Management Plan). Volume2C SmPC Summary of Product Characteristics: FD meddra .. Eudravigilance .. FD . ICSR (Individual Case Safety Reports). meddra /J 29 meddra /J 30. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 5. meddra WHO-UMC meddra . FDA AERS meddra 1997 11 WHO Uppsala Monitoring Centre ; UMC ICH . meddra meddra . meddra meddra . 2003 3 .. meddra .. WHO meddra WHOART . 2009 8 UMC VigiBase .. meddra VigiBase meddra . WHO MSSO WHOART . E2B FDA . meddra . 80% 2008-2009 . 2008 . AERS . meddra /J 31 meddra /J 32. Copyright (c) 2011 JMO Copyright (c) 2011 JMO.

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9 2008 9 Risk Risk meddra . Risk Risk meddra . Annex 229 . ICSR PSUR Signal detection meddra SMQ meddra Eudravigilance .. meddra /J 35 meddra /J 36. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 6. GUIDELINE ON THE USE OF STATISTICAL SIGNAL. Summary of Product Characteristics (SmPC) DETECTION METHODS IN THE. EUDRAVIGILANCE DATA ANALYSIS SYSTEM. This guideline will be included in The Rules Governing Medicinal Products in the European Union Volume 2C Notice to Eudravigilance . Applicants . CTD 1 . PRR Proportional Reporting Ratio . 4 3 4 4 4 8 meddra .

10 meddra meddra PT SOC SMQ . / . meddra EMA . meddra Access Policy . 1999 12 2005 .. 2 2009 9 2010 5 2008 12 .. meddra /J 37 meddra /J 38. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 7. meddra meddra /J meddra .. meddra . meddra . meddra /J 2009 7 . meddra /J . meddra /J . meddra /J meddra /J . Copyright (c) 2011 JMO 1 Copyright (c) 2011 JMO 2. PT: Preferred Term). meddra . Standaidisd meddra Queries (SMQ).. 85 26 19,086.. System Organ Class (SOC) PT LLT . 335 PT LLT .. High Level Group Term (HLGT). SOC . 1,710. High Level Term (HLT) SOC HLT, HLGT.