DD ISO/TS 22224:2009
Current
The latest, up-to-date edition.
Health informatics. Electronic reporting of adverse drug reactions
Hardcopy , PDF
English
30-11-2009
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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.
| Committee |
IST/35
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| 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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