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BSI
DD ISO/TS 22224:2009

DD ISO/TS 22224:2009

Current

Current

The latest, up-to-date edition.

Health informatics. Electronic reporting of adverse drug reactions

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2009

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Business processes in ADR reporting
5 Modification of ICH guideline (E2BM) for implementing
  electronic reporting of ADRs
6 ADR vocabularies
7 Other considerations
Bibliography

Specifies the electronic reporting of adverse reactions caused by drugs for human uses.

This Technical Specification encompasses the electronic reporting of adverse reactions caused by drugs for human uses. Thus, other businesses relating to adverse events caused by blood transfusions, medical devices and veterinary drugs are excluded from the scope of this Technical Specification.

Committee
IST/35
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO/TS 22224:2009 Identical

CFR 21(PTS500-599) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 500-599
CFR 21(PTS300-499) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 300-499

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Hardcopy - English
PDF - English
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