On 14 March 2024, the In Silico World project is holding a one-day workshop dedicated to discussing regulatory barriers to in silico trials. The workshop is organised by the University of Catania and it is accessible online free of charge, upon registration on Eventbrite. The workshop will be attended, among others, by some SIMCor consortium members including Charité, the VPH Institute, and Lynkeus.
The event will summarise the work done within the In Silico World project on the regulatory barriers that slow down the adoption of in-silico trials (i.e., the use of modelling and simulation to assess the risk of new medical products) for both medical devices and medicinal products. The workshop will conclude with a round table discussion on assessing the credibility of data-driven predictors.
The invitation is addressed to all academics, regulators, industry and policy makers interested in the regulatory aspect of the use of computer modelling and simulation in the development and regulatory certification of new medical devices.
The workshop programme is divided into two parts, one focused on the state of the art, i.e., the present, and the second on future perspective, i.e., the future.
Present
- Opening remarks – Francesco Pappalardo (Host and WP4 leader -In Silico World consortium)
- Review of current regulatory pathways in Europe and the USA to certify DTHs and MDDT/DDT – Cristina Curreli (In Silico World consortium)
- Principles and regulatory application of credibility assessment with ASME V&V 40-2018 – Jeff Bischoff (Zimmer-Biomet; chair of the ASME V&V40 committee)
- Bringing ASME VV-40 to the international level: the new IEC/ISO work group
Regina Geierhofer (Siemens Healthineers; Secretary of the IEC TC62) - Toward Good Simulation Practice: from position report to future technical standards
Vincenzo Carbone and Klaus Zeier (In Silico World consortium) - EMA Qualification advice on BoneStrength and on UISS-TB – Alessandra Aldieri and Giulia Russo (In Silico World consortium)
Future
- Credibility of Computational Models Program: new guidance from FDA-CDRH – Prasanna Pathmanathan (FDA-CDRH)
- Devices vs. Drugs: statistical inference approaches at the root of an epistemological divide Marco Viceconti (In Silico World consortium)
- Presentation and open discussion on the In Silico World Report on regulatory barriers to in silico methodologies
- Presentation and roundtable – Assessing the credibility of data-driven and hybrid models. Is a general credibility framework possible?
Marco Viceconti, Saverio Ranciani, Jeff Bischoff, Regina Geierhofer, Prasanna Pathmanathan
The full programme is accessible here: ISW Catania Workshop Agenda.