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

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