Signal Generation 167

13. WHO Programme—Global Monitoring 169

I. Ralph Edwards and Sten Olsson

14. Regulatory Pharmacovigilance in the EU 183

Patrick C. Waller and Priya Bahri

15. Spontaneous Reporting—UK 195

Sarah Davis and June M. Raine

16. Spontaneous Reporting—France 209

Nicholas Moore, Carmen Kreft-Jais and Alban Dahnani

17. Spontaneous Reporting—USA 219

David J. Graham, Syed R. Ahmad and Toni Piazza-Hepp

18. Algorithms 229

John A. Clark

19. Overview—Spontaneous Signalling 247

John A. Clark, Stephen L. Klincewicz and Paul E. Stang

20. Statistical Methods of Signal Detection 273

Stephen Evans

21. Statistical Methods of Evaluating Pharmacovigilance Data 281

Bernard Begaud

22. Data Mining 291

I. Ralph Edwards, Marie Lindquist, Andrew Bate and Roland Orre

23. Epidemiology of Adverse Events Associated with Epilepsy and Use of Lamotrigine 301

Patricia Tennis

24. Pharmacovigilance in the Netherlands 309

A.C. van Grootheest and E.P. van Puijenbroek

25. CIOMS Working Groups and their Contribution to Pharmacovigilance 317

Sue Roden

Saad A.W. Shakir

27. PEM in New Zealand 345

David M. Coulter

Douglas Steinke, Josie M.M. Evans and Thomas M. Macdonald

Louise Wood

30. Overview of North American Databases 379

Brian L. Strom and Judith L. Kinman

31. Pharmacovigilance in the HMO Research Network 391

Richard Platt et al.

32. Other databases in Europe 399

Miriam C.J.M. Sturkenboom

33. Surveillance for Medical Devices—USA 411

Thomas P. Gross and Larry G. Kessler

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