Harmonizing the Future: Global Regulatory Perspectives on In Silico Evidence
If we can submit in silico evidence for regulatory approval to the FDA, we still need to rely exclusively on clinical trial result to the rest of the world until regulation are harmonized!
Really? Let's ask the question to the regulators.
The Avicenna Alliance and Marc Horner, International Affairs Working Group Leader, are proud to invite you to attend the Regulatory Round Table entitled “Harmonizing the Future: Global Regulatory Perspectives on In Silico Evidence”, chaired by Tina Morrison, who will get firsthand opinions of regulators from all around the world, including European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), Ministry of Food and Drug Safety (MFDS), Medicines and Healthcare products Regulatory Agency (MHRA), Therapeutic Goods Administration (TGA), and the University of Ulsan.
This landmark session will reflect the Alliance’s commitment to advancing regulatory convergence and innovation in healthcare.
In silico evidence has the potential to reduce, refine, or replace traditional experimental and clinical data, enabling faster, more ethical, and more cost-efficient decision-making. However, differing regulatory expectations across regions continue to limit its broader adoption. Global harmonization is therefore essential to fully unlock its potential and modernize healthcare innovation.
The International Affairs WG has been actively driving this goal through direct engagement with competent authorities, the development of model credibility standards, and participation in international initiatives such as UK CEiRSI and IMDRF.
The round table, moderated by Tina Morrison (EQTYLab), Global Harmonization TF Leader, will highlight a shared global commitment to harmonising regulatory approaches for in silico evidence, reinforcing how collaboration can accelerate innovation while ensuring the highest standards of public health and safety.
Don’t miss this exceptional opportunity to hear from our experts, learn from their experience, and gain a glimpse of what the future holds.
