MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02380cam a2200289 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
9290360429 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9290360429 |
| 035 ## - |
|---|
| -- |
(Sirsi) 9290360429 |
| 060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
|---|
| Classification number |
QZ 42 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
900626s1990 1 0 eng |
| 110 2# - MAIN ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
CIOMS Working Group on International Reporting of Adverse Drug Reactions. |
| 245 00 - TITLE STATEMENT |
|---|
| Title |
International reporting of adverse drug reactions : |
| Remainder of title |
final report of CIOMS working group. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc. |
Geneva : |
| Name of publisher, distributor, etc. |
CIOMS, |
| Date of publication, distribution, etc. |
1990. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
66 p. |
| 520 3# - SUMMARY, ETC. |
|---|
| Summary, etc. |
Sets out a carefully developed and tested procedure for the standardized reporting, by manufacturers to regulators, of postmarketing adverse drug reactions occurring in foreign markets. The procedure, which is now published in its final form, is the culmination of a three-year project initiated by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO. The main part of the book presents and explains the CIOMS procedure for the international reporting of adverse drug reactions. The procedure, which was worked out and agreed upon by representatives of six regulatory agencies and seven multinational pharmaceutical companies, employs a uniform set of definitions and procedures, a fixed time-frame for submission of the report, and a reporting form with standardized elements and format. Prior to finalization, the scheme was pretested in a two-year pilot project involving seven manufacturers and some 40 affiliates. The second half of the book presents evaluations of the scheme prepared by each of the participating regulatory agencies and manufacturers. While pointing out some problems in the implementation of the scheme and use of the reporting form, these first-hand experiences overwhelmingly underscore the feasibility and utility of the scheme, which has already been adopted for use in the United Kingdom, the United States of America, the Federal Republic of Germany, and Italy. |
| 535 ## - |
|---|
| -- |
DC.CIOMS |
| 550 ## - ISSUING BODY NOTE |
|---|
| Issuing body note |
WHODOC |
| 561 ## - OWNERSHIP AND CUSTODIAL HISTORY |
|---|
| History |
WHO monograph |
| 596 ## - |
|---|
| -- |
4 |
| 650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical preparations |
| General subdivision |
adverse effects. |
| 650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug therapy |
| General subdivision |
adverse effects. |
| 650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Adverse drug reaction reporting systems. |
| 650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug industry. |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) |
|---|
| Topical term or geographic name as entry element |
Pharmaceuticals and Biologicals. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
Council for International Organizations of Medical Sciences. |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
NLM Classification Scheme |
| Koha item type |
Books |
