Venue: COBIS - M10, Ole Maaløes Vej 3, 2200 CPH N
Time: 14:30 - 17:00
DANISH BIO – DANSK BIOTEK & OZACK invite you to a workshop on the implications of the (not really) new EU Clinical Trials Regulation No 536/2014 (CTR) to smaller players in the world of pharma.
The CTR will finally become applicable on January 31st, 2022 – even though it has been in force since 2014, the Go-Live date has been postponed multiple times due to the complexities of the Clinical Trials Information System (CTIS). Fortunately, the CTR allows for a three-year transition period for the sponsors to fully prepare for the future of clinical research in the EU.
In this workshop, with the support from Lene Grejs Petersen from the Danish Medicines Agency (DKMA), we will summarize the key changes the CTR brings, demystify the complexities of the CTIS, and provide practical tips on how to tackle the challenges ahead.
To accommodate covid-19 restrictions, max. 50 people will be allowed at the event on a first come first served basis. Furthermore, face masks and sanitizer will be available to everybody.