DEVELOPMENT SAFETY UPDATE REPORT;
DRUG INFORMATION;
DRUG SAFETY;
ETHICS;
FOOD AND DRUG ADMINISTRATION;
LIFE CYCLE;
MASS COMMUNICATION;
MEDICAL DOCUMENTATION;
NOTE;
PERIODIC SAFETY UPDATE REPORT;
POSTMARKETING SURVEILLANCE;
PRIORITY JOURNAL;
ADVERSE DRUG REACTION REPORTING SYSTEMS;
COMMUNICATION;
DRUG APPROVAL;
DRUG TOXICITY;
DRUGS, INVESTIGATIONAL;
HUMANS;
PRODUCT SURVEILLANCE, POSTMARKETING;
RISK ASSESSMENT;
The development safety update report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials. Report of CIOMS Working Group VII. Geneva: CIOMS
The Council for International Organizations of Medical Sciences. The development safety update report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials. Report of CIOMS Working Group VII. Geneva: CIOMS, 2006
Draft consensus guideline. Development safety update report E2F. Current step 2 version [online] [Accessed 2009 Jan 26]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Draft consensus guideline. Development safety update report E2F. Current step 2 version, 2008 Jun 5 [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA4727.pdf [Accessed 2009 Jan 26]
ICH harmonised tripartite guideline. Clinical safety data management: periodic safety update reports for marketed drugs E2C (R1). Current step 4 ver-sion 2005 Nov [online] [Accessed 2009 Jan 26]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Clinical safety data management: periodic safety update reports for marketed drugs E2C (R1). Current step 4 ver-sion 2005 Nov [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA477.pdf [Accessed 2009 Jan 26]
The Council for International Organizations of Medical Sciences. Management of safety information from clinical trials. Report of CIOMS Working Group VI. Geneva: CIOMS, 2005
ICH harmonised tripartite guideline. Clinical safety data management: definitions and standards for ex-pedited reporting. Current step 4 version [online], [Accessed 2009 Jan 26]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Clinical safety data management: definitions and standards for ex-pedited reporting. Current step 4 version, 1994 Oct 27 [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA436.pdf [Accessed 2009 Jan 26]
Report of CIOMS Working Group III (second edition). Geneva: CIOMS
The Council for International Organizations of Medical Sciences. Guidelines for preparing core clinical safety information on drugs. Report of CIOMS Working Group III (second edition). Geneva: CIOMS, 1999
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use [online]. Available from URL: http://www. ich.org/cache/compo/276-254-1.html [Accessed 2010 Mar 30]
Pharmacovigilance during the pre-approval phases: An evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines
DOI 10.2165/00002018-200629080-00003
Hartford CG, Petchel KS, Mickail H, et al. Pharmaco-vigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines. Drug Saf 2006; 29 (8): 657-673 (Pubitemid 44175037)
Institute of Medicine of The National Academies. The fu-ture of drug safety: promoting and protecting the health of the public. Washington, DC: The National Academies Press, 2007
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline
[Accessed 2009 Jan 26] Pharmacovigilance planning E2E. Current step 4 version [online]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Pharmacovigilance planning E2E. Current step 4 version, 2004 Nov 18 [online]. Available from URL: http://www. ich.org/LOB/media/MEDIA1195.pdf [Accessed 2009 Jan 26]