-
2
-
-
33645015874
-
Revision of the ENGAGE Auditing Guideline: An optional guideline for good clinical practice compliance and quality management systems auditing
-
(compiler) (prepared by the Audit Working Party of the EFGCP)
-
Cheetham, B. (compiler) (2005), "Revision of the ENGAGE Auditing Guideline: an optional guideline for good clinical practice compliance and quality management systems auditing", International Journal of Pharmaceutical Medicine, Vol. 19, pp. 89-96 (prepared by the Audit Working Party of the EFGCP).
-
(2005)
International Journal of Pharmaceutical Medicine
, vol.19
, pp. 89-96
-
-
Cheetham, B.1
-
4
-
-
33846519073
-
-
EMEA, "The European Medicines Agency integrated quality management system", EMEA/MB/034/04, available at: www.emea.eu.int/pdfs/general/direct/ qms/ 003404 en.pdf
-
EMEA (2004), "The European Medicines Agency integrated quality management system", EMEA/MB/034/04, available at: www.emea.eu.int/pdfs/ general/direct/qms/ 003404 en.pdf.
-
(2004)
-
-
-
8
-
-
0029790973
-
A systems audit approach to non-standard systems in clinical research
-
Gittelson, P.L. (1996), "A systems audit approach to non-standard systems in clinical research", Drug Information Journal, Vol. 30, pp. 703-8.
-
(1996)
Drug Information Journal
, vol.30
, pp. 703-8
-
-
Gittelson, P.L.1
-
9
-
-
33846559218
-
-
GMP, GMP London Ch. 1
-
GMP (2004), EC Guide to GMP, GMP, London, Ch. 1.
-
(2004)
EC Guide to GMP
-
-
-
10
-
-
33846503569
-
-
HMSO, SI standard publication HMSO London
-
HMSO (1999), SI 1306/1999 Interpretation 1, SI standard publication, HMSO, London.
-
(1999)
SI 1306/1999 Interpretation 1
-
-
-
11
-
-
33846553869
-
-
ISO, "9001:2000 and FDA quality system", available at: www.fda.gov/cdrh/ devadvice/ ISO9001.pdf
-
ISO (2000), "9001:2000 and FDA quality system", available at: www.fda.gov/cdrh/ devadvice/ ISO9001.pdf.
-
(2000)
-
-
-
14
-
-
33846529651
-
-
"Understanding the role of the QP in clinical trials, David Begg Associates", paper presented at the MHRA Breakfast Forum on QP Transitional Arrangements, BMA House, London, 21 September
-
Russell, M. (2004), "Understanding the role of the QP in clinical trials, David Begg Associates", paper presented at the MHRA Breakfast Forum on QP Transitional Arrangements, BMA House, London, 21 September.
-
(2004)
-
-
Russell, M.1
-
15
-
-
31744445480
-
Setting the standard
-
Schnurr, B., Alzer, M. and Harrison, F. (2005), "Setting the standard", Good Clinical Practice Journal, Vol. 12 No. 5, pp. 29-31.
-
(2005)
Good Clinical Practice Journal
, vol.12
, Issue.5
, pp. 29-31
-
-
Schnurr, B.1
Alzer, M.2
Harrison, F.3
-
16
-
-
0028117870
-
Merging GCP and ISO 9000 requirements - A source of synergy in quality management of clinical research
-
Sweeney, F. (1994), "Merging GCP and ISO 9000 requirements - a source of synergy in quality management of clinical research", Drug Information Journal, Vol. 28, pp. 1097-104.
-
(1994)
Drug Information Journal
, vol.28
, pp. 1097-104
-
-
Sweeney, F.1
-
17
-
-
4444352201
-
How to implement ISO 9001 in a GCP/CRO environment
-
Summer, available at: www.inpharm.com/static/intelligence/pdf/MAG_243424. pdf
-
Tielemans, D. (2004), "How to implement ISO 9001 in a GCP/CRO environment", European Pharmaceutical Contractor, Summer, pp. 46-50, available at: www.inpharm.com/static/intelligence/pdf/MAG_243424.pdf.
-
(2004)
European Pharmaceutical Contractor
, pp. 46-50
-
-
Tielemans, D.1
-
18
-
-
33846494426
-
-
US Department of Health and Human Services, Food and Drug Administration (FDA), "Managing the risks from medical product use - creating a risk management framework. Part 2 - is the FDA maintaining the quality of its pre-marketing review?", report to the FDA Commissioner from the Task Force on Risk Management, available at: www.fda.gov/oc/tfrm/Part2.html
-
US Department of Health and Human Services, Food and Drug Administration (FDA) (1999), "Managing the risks from medical product use - creating a risk management framework. Part 2 - is the FDA maintaining the quality of its pre-marketing review?", report to the FDA Commissioner from the Task Force on Risk Management, available at: www.fda.gov/oc/tfrm/Part2.html.
-
(1999)
-
-
-
19
-
-
33846498171
-
-
"How to set up and manage QC and QA" paper presented at the BARQA 2004 Annual Conference - Compliance and Quality, Crowne Plaza, Liverpool, 10-12 November
-
Visschedijk-Brinkman, M. (2004), "How to set up and manage QC and QA" paper presented at the BARQA 2004 Annual Conference - Compliance and Quality, Crowne Plaza, Liverpool, 10-12 November.
-
(2004)
-
-
Visschedijk-Brinkman, M.1
|