The medical dictionary for regulatory activities (MedDRA): A survey of regulatory authorities' approaches to implementation

International Journal of Pharmaceutical Medicine

Volumn 12, Issue 1, 1998, Pages 23-27

  Brown, E G ^a   David, M ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; AUTHORITY; BOOK; DRUG INDUSTRY; DRUG SURVEILLANCE PROGRAM; EUROPE; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; INTERPERSONAL COMMUNICATION; JAPAN; NOMENCLATURE; ORGANIZATION; PRIORITY JOURNAL; STANDARDIZATION; UNITED STATES;

EID: 0031899633     PISSN: 13649027     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. Wood KL.The Medical Dictionary for Drug Regulatory Affairs (MEDDRA) Project. Pharmacoepidemiol Drug Safety 1994; 3:7-13
2. Wood KL, Coulson RA, Wood SM. MEDDRA: The basis for the new international medical terminology for regulatory purposes. ESRA Rapporteur 1995; 2:12-15.
3. Nelson R. AERS. Paper given at IBC Conference, London September 1997. In Brown E, Gardner J. Adverse drug reactions and adverse events. ID Weekly Highlights Current Drugs, October 1997; 22-27.
4. Fescharek R, Dechert G, Reichert D, Dass H. Overall analysis of spontaneously reported adverse events: a worthwhile exercise or flogging a dead horse? Pharm Med 1996; 10:71-86.
5. Brown EG, Clark E. Evaluation of MEDDRA in representing medicinal product data sheet information. Pharm Med 1996; 10:111-118.
6. 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; 11:85-89.