is a global non-profit organization, created in 2016, advocating for the regulation and deployment of in silico methods (i.e. computational modeling and simulation (CM&S)) for healthcare.
The 2022 Avicenna Days will update the entire healthcare community on recent progress and achievements related to the adoption and deployment of in silico methods. We will review the plans to make digital evidences and in silico methods a reality in academic and industrial research, for both regulatory and clinical applications.
Who should attend?
Any academic or industry researcher and leader involved in medical and pharmaceutical innovation,
Any Scientists and regulatory affairs professionals interested in digital evidence,
Clinicians and medical staff intrigued to understand how this technology will help them in their daily activities.
What will you learn?
1.Recent advances supporting in silico methods for research, regulatory and clinical activities, on the medical device, bio/pharma and treatment fields.
2.Academic, industry and regulatory leaders’ visions and timelines for larger scale adoption of in silico medicine.
3.Ask questions, express concerns, debate with experts and peers about important, immediate next steps to combine health care innovation and better patient safety.
Time: 14.00 – 18:30 CET / 13.00 - 17.30 BST / 18.30 - 23.00 IST / 8.00 - 12.30 EST / 7.00 - 11.30 CST
14:00 - 14:05 Welcome
Roberta Maggi, Office Manager, Avicenna Alliance
14:05 - 14:20 Introduction to Avicenna Alliance
Thierry Marchal, Secretary General, Avicenna Alliance
14:20 - 15:00 The Vision
·Creating a Modeling-Based Culture, Randy Schiestl, Boston Scientific
·Big data, AI and in silico trials based on multiscale modelling and simulation, Blanca Rodriguez, University of Oxford
·Role of Modeling and Simulation in Drug Development and Regulatory Decision-Making, Raj Madabushi, FDA
·Modeling and Simulation at the FDA, Pras Pathmanathan, FDA
15:00 - 15:40 The Achievements
·C4Bio - Community Challenge towards Consensus on the Characterization of Biological Tissue, Nele Famaey, KU Leuven, Chair ofTissue Characterization Task Force
·Engaging with Notified Bodies and other European Stakeholders, Simon Sonntag, Virtonomy, Chair of Notified Bodies Task Force
·Towards Global Harmonization - A Framework that Makes the Game Work, Marc Horner, Ansys, Chair of Global HarmonizationTask Force
15:40 - 15:55 BREAK
15:55 - 17:25 From a Technology Dream to a Regulatory Routine: an Ongoing, Successful Journey
·Sharing the Progress on In silico with the world,Mark Palmer, Medtronic, Leader of the International Affairs Working Group andthe International Affairs team;
·Adoption of in silico methods for European Regulatory Activities, Emmanuelle Voisin, VCLS, Leader of the Policy DevelopmentWorking Group and the Policy Development team;
·Avenues for funding and coordinating in silico Research, Liesbet Geris, VPHi, Leader of the Research & Technology Working Groupand the Research and Technology team.
17:25 - 18:15 Round Table
TheAvicenna Alliance Board will answer your questions and openly discuss key obstacles, opportunities, progress and achievements in front of us.
18:15 - 18:30 Wrap up
Thierry Marchal, Secretary General, Avicenna Alliance
Wednesday 16° February 2022
Time: 14.00 – 17:30 CET / 13.00 - 16.30 BST / 18.30 - 22.00 IST / 8.00 - 11.30 EST / 7.00 - 10.30 CST
14:00 - 14:05 Welcome & Introduction
Thierry Marchal, Secretary General, Avicenna Alliance
14:05 - 15:05 Regulatory Affairs Forum
In Silico in Practice: the view of Developers and Regulators
Speakers:
·Alejandro Frangi, University of Leeds, Chair of the UK Insilico Regulatory Task Force
·Francesco Pappalardo, University of Catania, Chair of the Pharmaceutical Strategy Task Force
·Michael Kipping, Innovate UK
Moderator:
Thierry Marchal, Ansys, Secretary General of the Avicenne Alliance
15:05 - 16:05 Regulatory Affairs Forum
Harmonization & Standardization: Where do we stand?
Speakers:
·Klaus Zeier, DIN
·Luca Emili, InsilicoTrials, Chair of the Good Simulation Practice Task Force
·Walter Schmidt, Stryker
·Angel Guzman Rodriguez, ASME
Moderator:
Marc Horner, Ansys, Chair of the Global Harmonization Task Force
