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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdPharmacovigilance
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; 184:1 |
Final version issued of Volume 9A on human pharmacovigilance in the EU. |
| CRA 2007; 185:3 |
COREC revises approval conditions for trials. |
| CRA 2007; 187:3 |
FDA and US industry tighten up on pharmacovigilance. |
| CRA 2007; 189:3 |
Steps taken to strengthen EU pharmacovigilance. |
| CRA 2007; 189:7 |
Further changes to Volume 9A on pharmacovigilance in
humans. |
| CRA 2007; 191:5 |
MHRA pharmacovigilance inspections report. |
| CRA 2007; 195:2 |
Common findings in pharmacovigilance inspections. |
| CRA 2007; 195:7 |
News from the DIA conference. |
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| 2006 |
|
|
CRA 2006; 163:10 |
Volume 9a for public consultation. |
|
CRA 2006; 163:10 |
Pharmacovigilance UK-specifics. |
|
CRA 2006; 164:3 |
Pharmacovigilance for vaccines. |
|
CRA 2006; 169:7 |
Draft pharmacovigilance guideline on monitoring of compliance with
obligations and inspections. |
|
CRA 2006; 169:7 |
Assessment of the EU pharmacovigilance system. |
| CRA 2006; 174:5 |
Pharmacovigilance obligations in Europe. |
|
CRA 2006; 176:12 |
EMEA final guideline on pharmacovigilance in children. |
|
CRA 2006; 177:6 |
EMEA finalises guideline on pharmacovigilance for medicines used by
children. |
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| 2005 |
|
| CRA 2005; 144:7 |
EU assessment of pharmacovigilance system. |
| CRA 2005; 150:4 |
Latest developments in pharmacovigilance inspections in the UK. |
| CRA 2005; 152:6 |
EMEA publishes final recommendations on working with Patients
Organisations. |
| CRA 2005; 154:2 |
Role of Qualified Persons for pharmacovigilance. |
| CRA 2005; 154:3 |
RPSGB reviews EU Directive 2001/20/EC implementation. |
| CRA 2005; 156:5 |
AIOPI now PIPA. |
| CRA 2005; 157:6 |
EMEA drafts guideline for pharmacovigilance in children. |
| CRA 2005; 157:7 |
FDA updates Vigibase. |
| CRA 2005; 157:8 |
GCP and pharmacovigilance. |
|
CRA 2005; 158:1 |
EMEA consults on draft guideline for pharmacovigilance in children. |
|
CRA 2005; 159:5 |
Passive surveillance is no longer adequate in modern pharmacovigilance. |
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| 2004 |
|
| CRA 2004; 124:1 |
Getting to grips with pharmacovigilance inspections. |
| CRA 2004; 127:2 |
Understanding EudraVigilance. |
| CRA 2004; 130:6 |
EudraVigilance training. |
| CRA 2004; 131:2 |
Highlights of changes and new material in the April 2004 revision of
the Detailed Guidances. |
| CRA 2004; 132:5 |
Study to assess European pharmacovigilance. |
| CRA 2004; 133:4 |
Pharmacovigilance using EudraVigilance. |
| CRA 2004; 133:7 |
EudraVigilance training programme. |
| CRA 2004; 135:8 |
Pharmacovigilance update. |
| CRA 2004; 137:7 |
EudraVigilance training. |
| CRA 2004;142:11 |
EMEA offers guidance on pharmacovigilance. |