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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdEuropean Medicines Agency (EMEA)
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; 183:6 |
EMEA launches EudraPharm, the European medicines database. |
|
CRA 2007; 183:6 |
SME Office: a successful first year. |
| CRA 2007; 185:5 |
Flexible trials pose regulatory questions. |
| CRA 2007; 185:7 |
New rules regarding access to EMEA documents. |
|
CRA 2007; 187:1 |
Annex 11 of GMP to be revised. |
|
CRA 2007; 190:7 |
EMEA annual report published. |
| CRA 2007; 191:2 |
EMEA releases draft guideline on first-in-man clinical
trials. |
| CRA 2007; 192:6 |
Coordination of pre-approval GxP inspections. |
|
CRA 2007; 193:6 |
EMEA guideline on trials in small populations. |
|
CRA 2007; 194:8 |
EU-US regulatory co-operation. |
|
CRA 2007; 195:8 |
EMEA Paediatric Working Party meets for last time. |
| |
|
| 2006 |
|
| CRA 2006; 164:1 |
EMEA work programme on the European risk-management
strategy. |
| CRA 2006; 166:8 |
EMEA's assessment reports (EPARS) now available to the
public. |
| CRA 2006; 167:7 |
EMEA updates timelines for review of product information. |
| CRA 2006; 167:7 |
EMEA prepares for Bulgaria and Romania as Member States. |
| CRA 2006; 168:7 |
Find out more about the EMEA. |
|
CRA 2006; 168:8 |
International co-operation on medicines regulation intensified. |
|
CRA 2006; 170:1 |
European Commission, not EMEA. |
|
CRA 2006; 170:3 |
EU guidance on post-authorisation data following exposure to medicines
during pregnancy. |
|
CRA 2006; 172:7 |
EMEA introduces faster scientific advice procedure. |
|
CRA 2006; 173:2 |
European Medicines Agency reflects on adaptive study design. |
|
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. |
|
CRA 2006; 179:1 |
Implementation of the Paediatric Regulation. |
|
CRA 2006; 179:2 |
New guideline on the ethics of clinical trials in children. |
| |
|
| 2005 |
|
|
CRA 2005; 144:1 |
EMEA releases guidance on the assessment of risk/benefit. |
|
CRA 2005; 148:4 |
New proposal on fees payable to EMEA. |
|
CRA 2005; 152:6 |
EMEA publishes final recommendations on working with Patients
Organisations. |
|
CRA 2005; 154:1 |
European Medicines Agency issues guidance on data elements for
transmission of ICSRs. |
|
CRA 2005; 155:1 |
EMEA finalises new procedure for EU pharmaceutical guidelines. |
|
CRA 2005; 156:7 |
EMEA makes statement on NSAIDs. |
|
CRA 2005; 157:2 |
New EMEA guidance on data monitoring committees. |
|
CRA 2005; 157:6 |
EMEA drafts guideline for pharmacovigilance in children. |
|
CRA 2005; 157:7 |
100,000th EMEA product. |
|
CRA 2005; 158:1 |
EMEA consults on draft guideline for pharmacovigilance in children. |
|
CRA 2005; 159:1 |
Industry concerns over EMEA proposals for paediatric medicines regulation. |
| CRA 2005; 160:1 |
New Detailed Guidance for CTA application and changes to
EudraCT. |
| CRA 2005; 162:8 |
EMEA provides opinion on medicines for use outside EU. |
| |
|
| 2004 |
|
|
CRA 2004; 123:1 |
Investigator challenges EMEA in attempt to overturn new product
marketing approval. |
|
CRA 2004; 124:4 |
New EU guidelines and regulations. |
|
CRA 2004; 126:2 |
European action plan to improve medicines. |
|
CRA 2004; 132:1 |
European Medicines Agency is born as EU introduces new pharmaceutical
legislation. |
|
CRA 2004; 134:6 |
EMEA sets out road map to 2010. |
|
CRA 2004; 137:10 |
New EMEA guidelines. |
|
CRA 2004; 142:11 |
EMEA offers guidance on pharmacovigilance. |
| |
|
| 2003 |
|
|
CRA 2003; 102:6 |
EMEA Working Party programmes. |
|
CRA 2003: 102:8 |
Urinary incontinence guidance. |
|
CRA 2003; 106:6 |
German GMP updates now on EMEA website. |
|
CRA 2003; 109:3 |
EU enlargement countries to join EMEA as observers. |
|
CRA 2003; 110:5 |
EMEA focuses on extremes of age. |
|
CRA 2003; 113:8 |
New EU Guidance documents. |
|
CRA 2003; 115:5 |
New EMEA inspections website. |
|
CRA 2003; 115:8 |
Latest EU guidance documents. |
|
CRA 2003; 118:6 |
EMEA and FDA exchange confidentiality agreements. |
|
CRA 2003; 118:6 |
EMEA reminds marketing authorisation holders of ICSRs. |
|
CRA 2003; 118:8 |
Consultation on EMEA transparency initiatives. |
|
CRA 2003; 119:3 |
EMEA non-standard abbreviations. |
|
CRA 2003; 120:6 |
Latest EMEA guidance documents. |
|
CRA 2003; 121:6 |
EMEA and FDA provide first parallel advice. |
|
CRA 2003; 122:1 |
What does the future hold for the EMEA? |
|
CRA 2003; 122:7 |
Latest EMEA documents. |
| |
|
| 2002 |
|
|
CRA 2002; 87:6 |
EU policy paper on safety transmissions. |
|
CRA 2002; 90:3 |
Good regulatory practices and quality systems. |
|
CRA 2002; 91:1 |
EMEA workshop for patients' organisations. |
|
CRA 2002; 91:7 |
Guidelines to be revised. |
|
CRA 2002; 91:7 |
New diabetes guideline adopted. |
|
CRA 2002; 91:7 |
EMEA centralised applications. |
|
CRA 2002; 101:6 |
Design of orphan drugs trials in children. |
| |
|
| 2001 |
|
|
CRA 2001; 62:1 |
Who should sign final study report? |
|
CRA 2001; 62:6 |
New EU guidance notes. |
|
CRA 2001; 63:6 |
EU Central Marketing Authorisation. |
|
CRA 2001; 66:2 |
National measures for orphan drug research. |
|
CRA 2001; 66:4 |
Guidance for paediatric trials. |
|
CRA 2001; 66:6 |
Guidance on CTD |
|
CRA 2001; 66:6 |
New EMEA chairman selected. |
|
CRA 2001; 67:6 |
EMEA orphan fee reductions. |
|
CRA 2001; 68:6 |
New EMEA documents. |
|
CRA 2001; 69:6 |
Same day release of CPMP opinions. |
|
CRA 2001; 73:1 |
EMEA releases opinion on placebo trials. |
|
CRA 2001; 73:4 |
EMEA/CPMP Position Statement on the use of placebo in clinical trials
with regard to the revised Declaration of Helsinki. |
|
CRA 2001; 74:2 |
EMEA role to expand significantly. |
|
CRA 2001; 75:1 |
Does the EMEA address public health needs? |
|
CRA 2001; 79:1 |
EMEA create new unit. |
| |
|
| 2000 |
|
|
CRA 2000; 42:6 |
EMEA catalogue of public documents.
|
|
CRA 2000; 44:6 |
EMEA adopt new guidelines.
|
|
CRA 2000; 44:6 |
New concept paper for asthma studies.
|
|
CRA 2000; 44:6 |
EMEA scientific advice.
|
|
CRA 2000; 44:6 |
How to find EMEA documents.
|
|
CRA 2000; 48:6 |
EMEA guidance on contraceptive trials.
|
|
CRA 2000; 52:2 |
Financial conflict guidance of interest to be reviewed.
|
|
CRA 2000; 55:6 |
Latest EMEA guidance.
|
|
CRA 2000; 56:6 |
EMEA has many orphans.
|
|
CRA 2000; 59:6 |
Quality of translations a problem. |
| |
|
| 1999 |
|
| CRA 1999; 19:2 |
EMEA to offer GCP support on the Internet. |
| CRA 1999; 21:1 |
New CPMP guidance documents released by EMEA. |
| CRA 1999; 22:3 |
New EMEA advice for trials on anti-rheumatics. |
| CRA 1999; 22:3 |
EMEA to update guidance note. |
| CRA 1999; 23:2 |
CEE countries may market EMEA-approved products. |
| CRA 1999; 23:6 |
EMEA improves its systems. |
| CRA 1999; 24:3 |
Proposed database for completed trials only?
|
| CRA 1999; 25:3 |
EMEA status report. |
| CRA 1999; 25:6 |
EMEA releases new guidelines.
|
| CRA 1999; 28:6 |
Flu vaccine composition announced.
|
| CRA 1999; 29:2 |
New guidance for contraceptives.
|
| CRA 1999; 30:6 |
Essential documentation and archiving.
|
| CRA 1999; 31:4 |
EMEA guidance for trials on heart failure.
|
| CRA 1999; 33:3 |
EMEA guidance for COPD trials.
|
| CRA 1999; 33:3 |
EMEA advice on readability.
|
| CRA 1999; 33:6 |
Guidance for MS trials.
|
|
CRA 1999; 37:6 |
EMEA code of conduct.
|
|
CRA 1999; 38:6 |
Biostatistics guidelines.
|
|
CRA 1999; 39:6 |
Advice for studies on epileptic disorders.
|
|
CRA 1999; 39:1 |
Orphan drug regulations – timetable of events.
|
| |
|
| 1998 |
|
| CRA 1998; 5:1 |
First EMEA co-ordinated inspection takes place.
|
| CRA 1998; 6:4 |
EMEA centralised approvals prove successful. |
| CRA 1998; 6:4 |
Facts about the EMEA. |
| CRA 1998; 8:4 |
Progress of the EMEA GCP inspection program. |
| CRA 1998; 12:4 |
New documents for implementation in January 1999. |