5_Pharma as Political Player - Abraham

5_Pharma as Political Player - Abraham - MEDICINES,...

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For personal use. Only reproduce with permission from The Lancet Publishing Group. MEDICINES, SOCIETY, AND INDUSTRY II 1502 THE LANCET • Vol 360 • November 9, 2002 • www.thelancet.com harmonisation of pharmaceuticals regulation. Health Risk Society 2001; 3: 113–28. 43 Idanpaan-Heikkila J. Impact and implementation of the ICH guidelines. D’Arcy PF, Harron DWG, eds. Proceedings of the fourth international conference on harmonisation. Belfast: IFPMA, 1998: 33–34. 44 Anon. IFPMA concerns on WHO health systems review. Scrip 2000; 2553: 15. 45 Garutti RJ. Clinical safety data management: definitions and standards for expedited reporting. In: D’Arcy PF, Harron DWG, eds. Proceedings of the second international conference on harmonisation. Belfast: IFPMA, 1994: 376. 46 Gordon AJ. Clinical safety data management: ICH guideline and reasoning. In: D’Arcy PF, Harron DWG, eds. Proceedings of the second international conference on harmonisation. Belfast: IFPMA, 1994: 384. 47 ICH. Guideline on the need for carcinogenicity studies of pharmaceuticals. Geneva: IFPMA, 1995.
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