Backpedalling on EMA’s “proactive publication of clinical-data” draft policy: Was it all just a window-dressing exercise? Who or what is the EMA afraid of?
Attachment: 20140520_ematransparencypolicy.pdf
Attachment: 20140520_ematransparencypolicy.pdf
Category: Press releases
Attachment: 20140520_ematransparencypolicy.pdf
EU Regulation on clinical trials: An urgent call for support to clinical data transparency
Attachment: letter_to_corepers_ctr.pdf
TRANSPARENCY IN THE PUBLIC INTEREST: How the EMA policy on publication and access to clinical-trial data could help save lives
The European Medicines Agency (EMA) draft policy on “publication and access to clinical-trial data” could pave the way to a new era in the disclosure of clinical data on medicines.
Attachment: sept2013_ema_transparencypolicy.pdf
Black triangle for medicines: positive move but poor implementation plan
The draft paper on the quality review of documentssubmitted for consultation by the EMA does not reflect the spirit of the new pharmacovigilance legislation, which is to prevent druginduced harm.