AdverseDrug Reaction: a response to a drug that is noxious, unintended andoccurs at doses normally used in man for the prophylaxis, diagnosisor therapy of disease, or for modification of physiologicalfunction. (WHO, 1976)

SeriousAdverse Event: an adverse event or suspected adverse reaction that,in he view of either the investigator or sponsor, results in any ofhe following outcomes: death, a life-threatening adverse event,inpatient hospitalization or prolongation of existinghospitalization, a persistent or significant incapacity orsubstantial disruption of the ability to conduct normal lifefunctions, or a congenital anomaly/birth effect.

Pharmacovigilance：the science and activities relating to thedetection, assessment, understanding and prevention of adverseeffects or any other possible drug-related problems.(WHO)

Post-authorization safety studies (PASS):pharmacoepidemiological study or a clinical trial carried out inaccordance with the terms of the marketing authorized medicinalproduct. A PASS can be either interventional or non-interventional[Directive 2001/83./EC]

Post-marketing surveillance (PMS): analysis of dataaccumulated typically for the purpose of detecting adversereactions after a medicinal product as been given marketingauthorization by a regulatory body.

PMS,passive: spontaneous reporting systems

PMS,active: active screening of existing datasets, such asobservational studies and electronic health records

Signal:

Reportedinformation on a possible causal relationship between an adverseevent and a drug, the relationship being unknown or imcompletelydocumented previously. (WHO)// Informationthat arises from one or multiple sources (including observationsand experiments), which suggests a new potentially causalassociation, or a new aspect of a known association, between anintervention and an event or set of related events, other adverseor benificial, that is judgeeed to be of sufficient likelihood tojustify verificatory action. (CIOMS VIII)

2.Regulations

TheConsensus guidelines on safety developed by CIOMS WorkingGroups

http://www.cioms.ch/index.php/publications/available-publications?task=showCategory catid=54