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Notify Booklet
1 INTRODUCTION
2 THE V&S CHAIN FOR MPHOs
3 VIGILANCE AND SURVEILLANCE: HISTORY AND BASIC ELEMENTS
4 MEDICAL PRODUCTS OF HUMAN ORIGIN (MPHO) - DONATION AND ETHICS
ANNEX 1. Notify Library - MPHO type taxonomy
5 TOWARDS A GLOBAL GOVERNANCE OF MPHO
6 THE V&S SYSTEM IS PRIMARILY A RESPONSIBILITY FOR HEALTH AUTHORITIES
7 ORGANIZATION FOR A COMPREHENSIVE - VIGILANCE & SURVEILLANCE SYSTEM
8 VIGILANCE & SURVEILLANCE - RECOGNITION RELIES ON HEALTH CARE STAFF
9 INVESTIGATING OCCURRENCES THAT COULD CAUSE HARM - LEARNING FROM ERRORS
10 PROJECT NOTIFY
11 THE NOTIFY DATABASE - LEARNING FROM VIGILANCE
12 RISKS ASSOCIATED WITH LIVING DONATION
13 HARM TO RECIPIENT - INFECTIONS
14 HARM TO RECIPIENT - NON INFECTIOUS BLOOD TRANSFUSION REACTIONS
15 HARM TO RECIPIENTS - MALIGNANCY
16 HARM TO RECIPIENTS - GENETIC TRANSMISSIONS - HPC
17 HARM TO RECIPIENTS - GENETIC TRANSMISSIONS - gamets and embryos
18 CHARACTERISTICS, HANDLING AND CLINICAL ERRORS
19 TRACEABILITY, AN ABSOLUTE PRE-REQUISITE FOR MPHO SAFETY
ANNEX 2. Notify Library - Adverse occurrence type taxonomy
REFERENCES
Background Documents
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FDA Safety Information and Adverse Event Reporting Programme
FDA Safety Information and Adverse Event Reporting Programme
http://www.fda.gov/BiologicsBloodVaccines/default.htm
