Ohlbe
★★★

France,
2025-07-10 18:25
(345 d 09:41 ago)

Posting: # 24408
Views: 1,895
 

 Danish Agency requesting submission of CDISC data [BE/BA News]

Post reply
Dear all,

Following a pilot phase, the Danish Medicines Agency has announced that they would request the submission of BE data in CDISC format for all national applications and for decentralised or mutual recognition procedures when they act as Reference Member State, from 1st September 2025.
—
Regards
Ohlbe
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
128 visitors (0 registered, 128 guests [including 35 identified bots]).
Forum time: 04:06 CEST (Europe/Vienna)

Science is simply common sense at its best that is,
rigidly accurate in observation, and
merciless to fallacy in logic.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5