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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdEuropean inspections
The following articles on this topic have been published in
CRAdvisor (CRA) – the year, issue number
and starting page number for each are listed below:
Back to index |
| 2007 |
|
|
CRA 2007; 184:6 |
Regulatory inspections of a CRO. |
| CRA 2007; 187:4 |
BARQA to pilot a GCP inspection database. |
| CRA 2007; 192:6 |
Coordination of pre-approval GxP inspections. |
| CRA 2007; 195:1 |
New approach to GCP inspections. |
|
CRA 2007: 195:3 |
New MHRA guidance on responding to inspection findings. |
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| 2006 |
|
| CRA 2006; 167:6 |
Documents, archiving and inspections - how much can the
sponsor help the trial investigator? |
|
CRA 2006; 181:1 |
Inspection findings to go on certificates. |
|
CRA 2006; 181:6 |
Experiences of regulatory inspections at a CRO. |
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| 2005 |
|
| CRA 2005; 151:5 |
Update on UK GCP inspection issues. |
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| 2004 |
|
| CRA 2004; 142:5 |
ICH inspection procedures. |
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| 2001 |
|
| CRA 2001; 71:6 |
Portuguese inspections close down firms. |
| CRA 2001; 78:1 |
Serious GCP deficiencies found in pivotal studies. |
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| 2000 |
|
| CRA 2000; 43:6 |
Japanese inspection in Europe. |
| CRA 2000; 44:1 |
First Japanese inspection in UK and Germany. |
| CRA 2000; 45:1 |
European inspections reveal safety reporting deficiencies. |
| CRA 2000; 46:1 |
MCA GCP inspections – current activities. |
| CRA 2000; 46:2 |
Report of another inspection by the Japanese. |
| CRA 2000; 49:4 |
Form FDA 1572 in Europe. |
| CRA 2000; 53:6 |
Inspections in Germany. |
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| 1999 |
|
| CRA 1999; 22:1 |
Demanding Austrian inspection experience. |
| CRA 1999; 25:6 |
New MCA appointment for inspections. |
| CRA 1999; 32:4 |
No sponsor warning for site inspections in Germany. |
| CRA 1999; 33:1 |
FDA Form 1572 and trials in Europe. |
| CRA 1999; 34:1 |
Japanese inspectors visit Europe. |
| CRA 1999; 38:1 |
French inspectors have contacted trial patients. |
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| 1998 |
|
| CRA 1998; 4:3 |
Lessons from Danish inspections. |
| CRA 1998; 5:1 |
First EMEA co-ordinated inspection takes place. |
| CRA 1998; 5:3 |
GCP compliance problems in the Netherlands. |
| CRA 1998; 7:2 |
Swedish sponsor sites escape inspection. |
| CRA 1998; 8:4 |
Progress of the EMEA GCP inspection program. |