This year’s annual conference of the German Quality Management Association (GQMA) took place form September 21st till September 22nd in Würzburg. The two-day program was very well compiled and covered the different areas of GxP. The different parallel sessions covered up-to-date topics in the fields of Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP), Good Distribution Practice (GDP), Good Clinical Operations Practice (GCP) and Good Manufacturing Practice (GMP).
On Thursday morning GQMA president Steffen König opened the conference in front of over 300 attendees which is a new record and shows the importance of the topics.
Digitalization was a big topic in nearly all fields. The challenge of paperless laboratories and e-archiving nearly effects everybody in the field of clinical studies sooner or later.
Picking the right system that will still work in 25+ years and allow access to all the data that is required to be stored by regulation authorities is a huge task. Not much longer than 25 years ago we believed floppy disks and CD-Roms were great inventions and safe devices to store our data on.
“Unfortunately there is no one size fits all solution,” stated Dr. Wolfgang Summa from Merck in his talk about Archiving of eClinical Systems and Data. Each company or hospital has to figure out a strategy for themselves and see what fits best the proprietary conditions. One important part in going digital is the implementation of an e-signature. In the US electronic signatures are already valid and sooner or later that will come true for Germany as well. “But there are 50 shades of e-signatures. Be careful to use the right one”, advises Summa.
The closing plenary session touched a much more general topic. Dr. Tanja Kneiper introduced Merck’s strategy to shift from a trial centric clinical trial towards a patient centric clinical trial. By implementing patient advisory boards at a very early stage Merck hopes to improve the trials in a way they are manageable in patient’s everyday life and therefore reduce the drop-out rate and optimize the screening results.
All talks and moderators were very well casted, which guaranteed a very high standard of the conference. A big compliment to the program committee, we are looking forward to next year’s conference in Bonn!