The PSDM group of the Biometrics Section (BMS) of the Netherlands Society for Statistics and Operations Research (VVS/OR) cordially invites you for the

Upcoming PSDM event

Programming and Statistics in Medical Device Investigations

—SAVE THE DATE—

Registration is open
To register, please reply with an email to PSDMMedDev@gmail.com

Tuesday November 8th, 2022
Time: 13:00
Location: Denksport Centrum Amersfoort, Amersfoort (see flyer for details)

Download Flyer

Speakers:
Rianne Tooten (Clinical Research Professional)
Mylène van Doorn and Fenna Hensen (OCS Life Sciences)
Remco van der Meer (Medtronic)
Corine Baljé-Volkers (Clin-Q)

Introduction:
Since the new Medical Device Regulation has come into effect, both the Medical Device companies as well as the companies that support them (like CROs) are struggling with the necessities for Medical Device clinical investigations.
At the event, you will get a general introduction of the changed landscape and three further presentations that will discuss concrete examples and challenges within programming and statistics in the setting of clinical research for medical devices.


Program

13:00 Registration, Coffee & Tea
13:30Transition from MDD to MDR – The Key Changes
Rianne Tooten (Clinical Research Professional)
14:00Clinical Trials with Medical Devices​ – Examples and Challenges in Statistical Programming
Mylène van Doorn and Fenna Hensen (OCS Life Sciences)
14:30Coffee break
15:00How do medical device trials specifically affect the programmers work
Remco van der Meer (Medtronic)
15:30Statistical Challenges in Medical Device Investigations
Corine Baljé-Volkers (Clin-Q)
16:00AOB and wrap up
PSDM board
16:10PSDM ANNUAL MEETING
PSDM board
16:25Networking drinks
Presentation abstracts will follow