On April 30 2021, 3-5pm, VPHi is organizing its first triple helix expertise exchange workshop.
A triple helix format refers to the active participation of academia, regulators and industry. Regulatory science related to in silico technologies is receiving more and more attention. Testimony to this are the ASME V&V40 standard for medical devices and the collaborative work ongoing to establish guidelines for the use of in silico models (beyond the pharmacometrics models) in the drug development context.
In this workshop, the focus is on in silico models of drug-device combinations. Several speakers from academia and industry will present the work they are doing in this space. Regulators will subsequently present the regulatory perspective on the evaluation of drug-device combinations and the open questions related to the credibility establishment of the in silico models. At the end of the workshop, a discussion between the presenters and participants will address these questions and identify additional challenges.
We hope to welcome you to this interactive workshop and that you will share with us your inputs and perspectives!
Here's the event's full program:
3pm: Liesbet Geris, VPHi (BE): Introduction & goals
3.03 - 3.21pm: Yu Feng, Oaklahoma State University (USA): respiratory drug delivery
3.21 - 3.39pm: Roberta Bursi, InSilicoTrials (NL): nasal inhaler
3.39 - 3.57pm: Maria Christina Gagliardi, CNR NANO (IT): drug eluting stents
3.57 - 4.15pm: Marc Horner, Ansys (USA): wearable insulin pump
4.15 - 4.40pm: Ine Skottheim-Rusten, NMA (N) & Flora Musuamba Tshinanu, FAGG (BE): Regulatory perspective & questions in drug-device interaction
4.40-5pm: General discussion
Please register here!
We look forward to meeting you at the workshop! This event is open to all people who are interested in the topic.
VPHi acknowledges support from the European Union’s Horizon 2020 research and innovation programme under grant agreements no 101016503, 101017578 and 101016496