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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdICH guidelines
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; 188:1 |
ICH proposals for Development Safety Update Report. |
| CRA 2007; 189:4 |
Drive for consistent, global periodic safety reporting for clinical
trials. |
| CRA 2007; 195:4 |
News from the ICH Steering Committee. |
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| 2006 |
|
| CRA 2006; 165:7 |
ICH finalises quality guidance. |
| CRA 2006; 166:7 |
ICH finalises two guidelines. |
| CRA 2006; 168:6 |
Predicting drug efficacy and safety in new regions. |
| CRA 2006; 176:1 |
ICH 7 cancelled. |
| CRA 2006; 176:11 |
Future ICH work focuses on safety. |
| CRA 2006; 178:4 |
GCP principles: comparison between UK regulations and ICH GCP
guidelines. |
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| 2005 |
|
| CRA 2005; 144:6 |
ICH reports progress. |
| CRA 2005; 148:6 |
Updated E2B(M) guideline plus questions and answers reaches Step 5. |
| CRA 2005; 155:7 |
ICH Q9 risk management document becomes available. |
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| 2003 |
|
| CRA 2003; 104:7 |
ICH essential documents improve GCP. |
| CRA 2003; 105:1 |
ICH process continues with good progress: CTD soon mandatory. |
| CRA 2003; 105:8 |
ICH GCP guidelines changed in July - did you know? |
| CRA 2003; 109:4 |
More essential Essential Documents. |
| CRA 2003; 116:2 |
ICH continues to make good progress: report from July Steering
Committee meeting. |
| CRA 2003; 122:2 |
ICH continues to set standards for global drug development: report
from ICH 6. |
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| 2001 |
|
| CRA 2001; 61:6 |
New ICH guidance. |
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| 2000 |
|
| CRA 2000; 41:4 |
Advice for studies of angina or heart attack. |
| CRA 2000; 42:2 |
ICH E2C and the Periodic Safety Update Report. |
| CRA 2000; 48:3 |
The current status of ICH products in the ‘efficacy’ classification.
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| 1999 |
|
| CRA 1999; 24:2 |
ICH GCP to be the defined standard. |
| CRA 1999; 33:6 |
ICH E10 Guidelines. |
| CRA 1999; 34:4 |
New ICH guidance on choice of control group. |
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| 1998 |
|
| CRA 1998; 5:2 |
FDA version of ICH GCP guidelines is different from Step 4 document. |
| CRA 1998; 13:4 |
“Administrative changes” made to the ICH GCP Guidelines. |
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|
| 1997 |
|
| CRA 1997; 1:3 |
Aims of phases I to IV redefined in new ICH document. |