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REPORTING ADVERSE DRUG REACTIONS
DEFINITIONS OF TERMS AND CRITERIA FOR THEIR USE
REPORTING ADVERSE DRUG REACTIONS
Definitions of Terms and Criteria for their Use
Geneva
Copyright # 1999 by the Council for International Organizations of Medical Sciences (CIOMS)
ISBN 92 9036 071 2
Printed in Switzerland Reprinted 2000
EDITORIAL GROUP
Z. Bankowski R. Bruppacher I. Crusius
J. Gallagher G. Kremer J. Venulet
The Council for International Organizations of Medical Sciences (CIOMS) is a nongovernmental organization established jointly by the WorldHealthOrganizationandUNESCO in1949,withamandatetocollaboratewith the United Nations and its specialized agencies. Its international membership, consisting of international unions and federations of national associations and societies, represents a substantial proportion of the world’s biomedical scientific community. Its secretariat is located inGeneva inofficesmadeavailable by the World Health Organization.
A dominant theme of CIOMS for some time has been the ethical aspects of biomedical technology and the bioethical considerations to be taken into account in determining and implementing health policy.
A particular aspect of biomedical technology, the development and use of drugs, has been a second major theme. The independent status of CIOMS has permittedittocoordinatethecontributions of research-based pharmaceutical companies, national drug regulatory authorities, and representative bodies of medical specialties to harmonizing and strengthening drug-safety surveillance measures.
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