This seminar is arranged by Medicoindustrien’ s Expert group for clinical investigations and kindly hosted by Coloplast.
The aim of the day is to see what is in the future of the clinical area for medical devices and also meet peers working with clinical evaluations, clinical investigations and post market clinical follow-up and exchange experience.

Agenda
08.30 – 09.00  Check in & breakfast

09.00 – 09.05  Welcome & introduction, Pernille Trøjgaard, Coloplast

09.05 – 09.30  ISO 14155 update – process & what is new, v/Pernille Trøjgaard

09.30 – 10.15    Statistics for dummies v/NN colleague

10.15  – 10.30    Coffee break  

10.30 – 11.00     Estimants 
       
11.00 – 11.15       Introduction to group sessions: 3 topics:  PMCF,
                         Real World Evidence & Patient recruitment & retention
                         Please sign up for the groups sessions you wish to attend

11.15  – 12.00     Group sessions

12.00 – 13.00    Lunch & networking              

13.00 – 13.45    Clinical investigations in Denmark & update on European
                         activities, including how industry could improve their
                         application and other tips & trics?
                         v/Kristin Jøranli Astrup og Rasmus Øhrstrøm, DKMA

13.45 – 14.30    Group discussions, coffee & cake to bring to the group rooms

14.30 – 15.00    Ethical Committee: How can industry provide benefits for
                         patients participating in clinical investigations, tentative (TBC)

15.00 – 15.15    Wrap up of group discussions & conclusion of the day