 |
A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdInvestigational product
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; 183:4 |
FDA proposes new rule for experimental drugs. |
| CRA 2007; 190:4 |
How to avoid inspection problems with the product
specification file. |
| CRA 2007; 191:4 |
EC guidance on IMPs and non-IMPs. |
|
CRA 2007; 195:7 |
Biological samples and trials in Russia. |
| |
|
| 2006 |
|
| CRA 2006; 180:2 |
QP release of IMP documentation at study site. |
|
CRA 2006; 182:7 |
IMP or non-IMP? |
| |
|
| 2005 |
|
| CRA 2005; 152:8 |
New guidance for trial pharmacists. |
| CRA 2005; 176:11 |
QP certificate may be required at study site. |
| |
|
| 2004 |
|
| CRA 2004; 130:7 |
Guidance on transitional arrangements for QPs. |
| CRA 2004; 131:2 |
Highlights of changes and new material in the April 2004
revision of the Detailed Guidances. |
| |
|
| 2002 |
|
| CRA 2002; 81:2 |
New draft of Annex 13 now available. |
| CRA 2002; 83:6 |
Mutual Recognition Agreement closer for GMP. |
| CRA 2002; 93:2 |
Requirements for export of investigational drugs to
change. |
| |
|
| 2001 |
|
| CRA 2001; 72:4 |
Trade mark problem threatens quality of EU products. |
| CRA 2001; 74:6 |
Drug makers receive BSE warning. |
| CRA 2001; 75:5 |
EU GCP Directive and IMPs. |
| |
|
| 2000 |
|
| CRA 2000; 40:1 |
Do monitors break the law by collecting trial materials
from the site? |
| CRA 2000; 43:4 |
Clinical supplies or clinical surprise! |
| CRA 2000; 44:5 |
Clinical supplies of clinical surprise – part 2. |
| CRA 2000; 46:6 |
EU Pharmaceutical and Cosmetics Unit. |
| |
|
| 1999 |
|
| CRA 1999; 19:3 |
NLN’s correct use of medicines. |
| CRA 1999; 22:4 |
‘Just-in-time’ shipping. |
| CRA 1999; 22:4 |
Import of trial drugs made easier in Russia. |
| CRA 1999; 24:3 |
All investigational products must comply with GMP. |
| CRA 1999; 24:4 |
Investigational product for trial purposes cannot be sold. |
| CRA 1999; 24:5 |
Qualified person required. |
| CRA 1999; 29:6 |
Better training on product accountability. |
| CRA 1999; 36:6 |
“Deadly pills in UK.” |
| |
|
| 1998 |
|
| CRA 1998; 6:1 |
Details of destruction of trial supplies needed. |
| CRA 1998; 9:4 |
Resistance against ruling on destruction of trial
supplies. |
| CRA 1998; 12:5 |
BSE from medicines? |
| CRA 1998; 12:6 |
TSE Certificates for comparator drugs bought in the USA. |
| CRA 1998; 13:2 |
Understanding expiry dates. |
| CRA 1998; 13:5 |
Trial products and labelling. |
| CRA 1998; 14:4 |
A practical approach to the retention of trial materials. |
| CRA 1998; 15:1 |
Annex 13 of the Guide to Good Manufacturing Practice. |
| CRA 1998; 16:3 |
FDA working party on pregnancy labelling. |