On 14 juni 2017 the Department of Orthopedic Surgery MaastrichtUMC+ and Chemelot InSciTe present:
'From bench to Bedside'
'First-in-man' medical device clinical trials Symposium
At the NH Hotel, Maastricht
Limburg and the Netherlands as a whole are aiming to become innovation leaders in the field of regenerative medicine from a biomedical materials based approach. Clinical introduction of new medical devices or biomedical material based therapies is the pinnacle in the biomedical research valorization chain. The setup and successful realization of first-in-man medical device clinical trials are immense challenges requiring elaborate planning and documentation. Expert speakers will cover all relevant aspects in an effort to provide guidance on the path towards CE mark! Topics will include everything from design dossier verification to regulatory affairs and medical ethical approvals. The day will end with an interactive panel discussion and a networking drinks session!
For handouts of the Presentations given at this symposium: see the bottom of this page.
9:30 – 10:00
10:00 – 10:15
10:15 – 10:45
Motivation for Organizing the Symposium: Current Preclinical Research
at the Department of Orthopedic Surgery Maastricht UMC+
Paul Willems, orthopedic surgeon MUMC+
10:45 - 11:15
The IGZ and first-in-man medical device clinical studies
Paul Riem Vis
11:15 - 12:00
Legal issues relating to clinical investigation of medical devices
Erik Vollebregt, life sciences and IP lawyer
12:00 - 13:00
13:00 – 13:45
Biological safety evaluation of medical devices:
A risk management process
Jeannette van Loon, Medical Device Project BV
13.45 – 14:30
First-in-Man clinical study:
Now you know what, but do you know how?
Joris Bannenberg CMO Factory CRO
14:30 – 15:00
15:00 – 15:45
Your assistant: the legislation for medical devices.
Peter Ruys, Expert consultant in international medical device regulations
15:45 – 16:15
Journey of a novel tissue repair treatment:
from idea to market
16:15 – 17:00
|17:00 - 18:00|
For questions regarding this symposium please contact the Trialbureau of the orthopedics department:
- Mail to: firstname.lastname@example.org
- Tel : 043 387 7144
- Trialbureau Orthopedics department, MaastrichtUMC+
- P Debyelaan 25, 6229 HX Maastricht, Room number: H4 C2 0.10
Pieter Emans MD PhD – Orthopedic Surgeon MUMC+, knee specialist, special interest in osteoarthritis related fundamental, preclinical and clinical research.
Alex Roth PhD – Postdoctoral researcher MUMC+, biomedical engineer, project member in the SyCaP and PoSTuRE Chemelot InSciTe projects.
Liesbeth Jutten MSc – Study coordinator of Orthopaedic and related studies, project member of “informed consent” project
Annabel Janssen MA - Marketing Communications Manager Chemelot InSciTe
Special thanks to Philip Storey, Caymedic BV for the idea of this symposium, and Alwin van den Broek, Factory CRO for the support in organizing this symposium.