Registration
Description
Do you actively develop medical devices, diagnostic solutions, tissue engineering products, medical equipment or pharmaceuticals?
Do you know that regulatory authorities recommend computer modelling and simulation to accelerate the regulatory approval process of new products?
Join us for this seminar to learn best practices adopted by innovative companies using engineering simulation to accelerate both product development and the regulatory approval process.
Today, more and more innovative products in respiratory, cardiovascular, orthopedic, diagnostic and neurologic sectors to mention a few benefit from computer modeling and simulation to speed product development and ease the regulatory approval process.
The Food and Drug Administration (FDA) and the European Medicine Agency (EMA) are aware of the challenges in bringing new treatments to market as quickly as possible without compromising patient safety. For many years, the FDA has recognized the potential value of computer-based clinical models and is encouraging the adoption of this technology.
BioWin, the health cluster of Wallonia, and the premium sponsor ANSYS, invites you to this afternoon session with the following program :
15h00 - 15h30: Registration and welcome coffee
15h30 - 15h40: Presentation of the Health ecosystem in Wallonia and its main technological areas
Marianne Ghyoot - Associate Director, R&D and Process Management at BioWin
Laurence Timmermans - Innovation & Technological Partnerships Developer at BioWin
15h40 - 16h05: Growing importance of engineering simulation in the life sciences industry - Concrete examples
Thierry Marchal - Global Industry Director at ANSYS Inc
Case study 1: Implanted cardiovascular medical device
Boubker Ait Brik - Simulation department manager at Cardiatis
Case study 2: Bone regeneration and tissue engineering applications
Liesbet Geris - Professor at the Department of Aerospace and Mechanical Engineering at Université de Liège (ULg)
16h05 - 16h45: Use of simulation for the regulatory process approval - European Perspective
Adriano Henney - Executive Director at VPH Institute
Case study 3: Functional respiratory imaging
Jan Debacker – CEO at Fluidda
16h45 - 17h00: Coffee break
17h00 - 17h40: Use of simulation for the regulatory process approval - North America Perspective
Dawn Bardot – Senior Program Manager, Modeling & Simulation at Medical Device Innovation Consortium (MDIC)
Marc Horner – Lead healthcare specialist at ANSYS North America
17h40 – 18h00: Wrap-up & Panel Discussion
18h00 – 18h30: Cocktail & networking
Your objectives:
- Gain awareness of computer modeling and simulation
- Understand how regulatory authorities deal with this technology
- Learn about the concrete benefits obtained by early adopters
- Network with leaders using computer modeling and simulation
- Challenge solution providers to assist you with your specific products.
Public targets:
- Companies developing or with already existing products on the market
- Regulatory affairs companies
- Researchers working in mathematical modeling
- Engineering services
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Event
Product regulatory approval process: The role of computer modelling & simulation
1348 Louvain-La-Neuve
BELGIUM
Organizer contact
BioWin
Laurence Timmermans (0032 71 25 10 26) - Marianne Ghyoot (0032 71 25 10 23)
Address : Avenue Georges Lemaître 19
6041 Gosselies
BELGIUM
Site : http://www.biowin.org
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Attendees
- ANSCIAUX - Emilie
- BECHET - Sabrina
- BERNARDI - Alessandro
- BROSSARD - Gabriel
- BRUCHER - Luc
- CRASSON - Oscar
- DASNOY - Sébastien
- DEBRUE - Pascal
- GODFROID - Edmond
- GRAMME - Pierre
- GRELL - Anne-sophie
- GUYAUX - Michel
- MASQUELIER - Aurelie
- MEIJERS - Patricia
- NEMEGHAIRE - Stéphanie
- ROMMEL - Eddy
- ROY - Cecile
- SPATARO - Stéphane
- VAN STAVEREN - Wilma