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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdOther Directives
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 |
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CRA 2007; 186:8 |
Find national implementation measures for Directives using EUR-Lex. |
|
CRA 2007; 187:2 |
European Commission issues guidelines for paediatric investigation plans. |
| CRA 2007; 189:3 |
Steps taken to strengthen EU pharmacovigilance. |
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| 2006 |
|
| CRA 2006; 176:2 |
European Commission publishes first draft of Notice to
Applicants, Volume 10, on clinical trials. |
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| 2005 |
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| CRA 2005; 144:4 |
European Directives affecting clinical trials in 2005: an
overview. |
| CRA 2005; 145:1 |
European Commission issues Q&A document on implementing GCP
requirements in Europe. |
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| 2004 |
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| CRA 2004; 123:6 |
New EU GMP Directive. |
| CRA 2004; 132:4 |
EU Directive 2001/83 superseded. |
| CRA 2004; 132:5 |
New Directive on tissues and cells. |
| CRA 2004; 135:8 |
Pharmacovigilance update. |
| CRA 2004; 140:6 |
Consolidated Directive 2001/83/EC. |
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| 2003 |
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| CRA 2003; 106:6 |
New directive on human blood and blood components now in
force. |
| CRA 2003; 115:5 |
Annex 1 to Directive 2001/83/EC now available. |
| CRA 2003; 116:3 |
Annex to EC Directive 2001/83 is revised. |
| CRA 2003; 120:6 |
EU formalities on Directive 2001/83/EC modification. |
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| 2002 |
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| CRA 2002; 84:6 |
Registration for herbal medicines. |
| CRA 2002; 86:1 |
EU Directive on traditional medicines criticised. |
| CRA 2002; 90:1 |
EU Directive 2001/83/EC requires adherence to Helsinki 2000. |
| CRA 2002; 93:8 |
EU Directive 2001/83/EC revision. |
| CRA 2002; 99:1 |
Marketing authorisation directive already out of date. |
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| 2000 |
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| CRA 2000; 40:6 |
New data protection law. |
| CRA 2000; 41:3 |
Explicit consent may avoid data problems. |
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| 1999 |
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| CRA 1999; 35:1 |
Data protection Directive does effect clinical trials. |
| CRA 1999; 37:6 |
EC codifies guidelines. |
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| 1998 |
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| CRA 1998; 11:1 |
Are you ready for the Data Privacy Directive? |
| CRA 1998; 12:6 |
TSE Certificates for comparator drugs bought in the USA.
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