News items 2015
-
Good laboratory practice in non-clinical trials
| 29 July 2014 |
Clinical Trials Facilitation Group (CTFG) has prepared a document describing the requirements as to good laboratory practice (GLP) in non-clinical trials.
-
Danish Pharmacovigilance Update June 2014
| 17 July 2014 |
The June issue of Danish Pharmacovigilance Update.
-
Changed procedure for information on duplicate closed and nullified closed cases (updated)
| 15 July 2014 |
The new process for dispatching adverse reaction reports (ASPR) will be implemented on 12 and 13 July 2014.
-
Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - July 2014
| 15 July 2014 |
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 7-10 July 2014.
-
Danish Pharmacovigilance Update May 2014
| 14 July 2014 |
In the May issue of Danish Pharmacovigilance Update: Assessment of risk of serious anaphylactic reactions from treatment with ferumoxytol (Rienso), ADR reports for the HPV vaccine and the Danish Health and Medicines Authority’s annual pharmacovigilance report 2013.
-
Monitoring of medicines for births
| 07 July 2014 |
The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour. The action plan was launched in the autumn of 2013 following a public debate about the use of these medicines, and it should be completed by the end of 2015.
-
More clinical trials to Denmark
| 03 July 2014 |
The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.