Workshop on clinical evaluations and investigations with medical devices
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