The Medical Dictionary for Regulatory Activities (MedDRA)

Drug Safety

Volumn 20, Issue 2, 1999, Pages 109-117

  Brown, Elliot G ^a   Wood, Louise ^a   Wood, Sue ^a  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG CONTROL; DRUG INFORMATION; DRUG LEGISLATION; DRUG SURVEILLANCE PROGRAM; NOMENCLATURE; PRIORITY JOURNAL; REVIEW;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DICTIONARIES, MEDICAL; DRUG APPROVAL; EUROPE; HUMANS; INTERNATIONAL COOPERATION; PRODUCT SURVEILLANCE, POSTMARKETING; WORLD HEALTH;

EID: 0032991290     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-199920020-00002     Document Type: Review

References (15)

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2. Mitchard M, Wood L. Regulatory communications. Eur Pharm Law Notebooks 1996; II: 139-55
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4. Wood KL. Rapporteur's progress report. In: d'Arcy PFD, Harron DWG, editors. Proceedings of the Third International Conference on Harmonisation. Nov 1995, Yokahama. Belfast: Queens University Belfast Publications, 1996: 495-8
5. st Century. Buffalo Grove (IL): Interpharm Press Inc., 1998: 299-332
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9. Brown EG. Medical terminology: a view from Europe. In: DArcy PFD, Harron DWG, editors. Proceedings of the Third International Conference on Harmonisation. Nov 1995, Yokahama. Belfast: Queens University Belfast Publications, 1996: 500-3
10. Brown DR, Brown EG, Moulvad TB. A comparison of two medical terminologies in coding and analysing clinical trial safety data. Int J Pharm Med 1997; 11: 85-9
11. White C. A preliminary assessment of the impact of MEDDRA on adverse event reports and product labeling. Drug Inform Assoc J 1998; 32: 347-62
12. Tsutani K. View from Japan. In: d'Arcy PFD, Harron DWG editors. Proceedings of the Third International Conference on Harmonisation. Nov 1995, Yokahama. Belfast: Queens University Belfast Publications, 1996: 503-12
13. Brown EG, David M. The medical dictionary for regulatory activities (MedDRA): a survey of regulatory authority approaches to implementation. Int J Pharm Med 1998; 12: 23-7
14. ten Ham M. WHO and international terminology. In: d'Arcy PFD, Harron DWG, editors. Proceedings of the Third International Conference on Harmonisation. Nov 1995, Yokahama. Belfast: Queens University Belfast Publications, 1996: 514-6
15. MEDDRA: setting a new standard in medical terminology. [editorial]. Int J Pharm Med 1997; 11: 248