A model for the future conduct of pharmacovigilance

Pharmacoepidemiology and Drug Safety - Tập 12 Số 1 - Trang 17-29 - 2003
P.J. Waller1, Stephen Evans
1Post-Licensing Division, Medicines Control Agency, London, UK. [email protected]

Tóm tắt

AbstractA scientific model to support excellence in pharmacovigilance has been developed from first principles by brainstorming sessions and discussions with experts in the field. The model represents a long‐term vision of how pharmacovigilance could be conducted in the future. So far it has been developed without any consideration of constraints such as resources or the need for legislative change. Although the vision is holistic, it would be possible to test and implement parts of the model in a piecemeal fashion. Copyright © 2002 John Wiley & Sons, Ltd.

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Tài liệu tham khảo

10.1002/(SICI)1099-1557(199611)5:6<363::AID-PDS249>3.0.CO;2-7

Rawlins MD, 1995, Pharmacovigilance: paradise lost, regained or postponed?, J R Coll Physicians Lond, 29, 41

10.1002/(SICI)1099-1557(199912)8:7<535::AID-PDS456>3.0.CO;2-D

Burley DM, 1988, The rise and fall of thalidomide, Pharm Med, 3, 231

10.1001/jama.279.15.1200

Wilson AB, 1986, Monitoring for Drug Safety

Grahame‐Smith DG, 1987, Adverse Drug Reactions, 201

10.1046/j.1365-2125.1998.00774.x

10.1016/S0197-2456(95)80006-9

Waller P, 2000, Pharmacovigilance, Past Present and Future: Proceedings of the Susan Wood Symposium, 26

10.2165/00002018-200124020-00001

10.1136/bmj.323.7315.706

10.2165/00002018-199819010-00001

D'Arcy PF, 1996, Proceedings of the Third International Conference on Harmonisation Yokohama 1995

CIOMS IV Working Group, 1998, Benefit‐risk balance for marketed drugs: evaluating safety signals

CIOMS III/V Working Group, 1999, Guidelines for preparing core clinical safety information on drugs

Committee on Safety of Medicines/Medicines Control Agency, 2000, When you see the black triangle, Curr Probl Pharmacovig, 26, 8

10.1136/bmj.317.7155.405

10.1002/pds.706

The Uppsala Monitoring Centre, 1998, Effective Communications in Pharmacovigilance: The Erice report

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Thông tin xuất bản

Pharmacoepidemiology and Drug Safety

Tập 12 Số 1

17-29

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