BIOSPAIN 2026

Artificial intelligence is transforming medical devices, particularly software-based technologies for early disease detection and personalised healthcare. However, in 2026 AI-powered medical devices in Europe will operate under a dual regulatory framework shaped by Regulation (EU) 2017/745 (MDR) and the Artificial Intelligence Act, creating one of the most complex compliance environments globally.
This session will bring together a Notified Body representative, a startup with an AI-based speech analysis platform for early detection of dementia, Parkinson’s disease and cardiovascular conditions, and regulatory strategy experts. The panel will provide a multidisciplinary and practice-oriented discussion on how innovative AI solutions can successfully reach the European market.
Key discussion points include:

• Qualification and classification of AI-based software as medical devices
• Clinical evidence expectations for machine learning systems
• Lifecycle management of adaptive algorithms
• Interaction between MDR and the AI Act requirements
• Data governance and high-risk AI systems
• Regulatory pitfalls and common deficiencies identified by Notified Bodies
• Strategic considerations for startups scaling internationally

The discussion will address whether Europe can maintain global competitiveness in digital health while ensuring patient safety and regulatory robustness. By combining regulatory authority perspective, industry experience and strategic advisory insight, this session offers a practical roadmap for innovators navigating AI medical device development in Europe.

1. Conselleiro de Educación, Ciencia, Universidades y FP (Nota: Este seria nuestro Conselleiro, es donde esta integrada la Agencia Gallega de Innovación(GAIN))
Román Rodríguez González
Mails:
[email protected] (Conselleiro de Educación, Ciencia, Universidades y FP)
[email protected] (Jefe Gabinete Conselleiro)
[email protected] (Secretaria Conselleiro)
2. Conselleiro de Sanidad
Antonio Gómez Caamaño
Mails:
[email protected] (Conselleiro de Sanidad)
[email protected] (Jefa Gabinete Conselleiro)
[email protected] (Secretaria Conselleiro)

Regional biotechnology clusters and associations play a vital role in strengthening the biotechnology ecosystem by promoting collaboration among stakeholders, facilitating knowledge transfer, and accelerating the scientific and business development of the sector. Their work enhances the competitiveness of biotechnology companies while reinforcing the innovation and growth potential of their respective regions.

The aim of this session is to examine the role of biotechnology clusters in the development of the sector, explore how they collaborate with one another, and identify the key strengths and challenges across different regions, highlighting both shared priorities and the distinctive characteristics of each regional ecosystem. The discussion will also address the Biotech Act proposal to promote networks of biotechnology clusters as a means of strengthening competitiveness and fostering collaboration across the European biotechnology sector.

Propuesta de Ponentes: 

Moderador: Acesabio o bien AseBio y metemos a Acesabio como ponente?

• Idoia Muñoz, Directora del BHC
• Robert Fabregat, Director general de Biocat
• Jesús Agüero, Director Bioval
• Zara Pons, General Manager BIOIB
• Loli Pereiro, Manager Bioga

Human-derived substances are at the forefront of a new wave of biomedical innovation, spanning cell therapies, microbiome-based interventions, and advanced medicinal products. As these technologies rapidly evolve, so too does the complexity of the regulatory landscape governing their development and clinical application within the European Union.
This session will explore the scientific, clinical, and regulatory dimensions of substances of human origin (SoHO), with a focus on how emerging frameworks aim to balance patient safety, ethical considerations, and innovation. Experts will provide insights into the latest EU regulatory developments, including classification challenges, compliance pathways, and the implications of the evolving SoHO regulation.
A featured perspective from industry will highlight real-world translation, showcasing how cutting-edge companies—such as those working in microbiome therapeutics—navigate regulatory uncertainty while advancing novel therapies toward the clinic. The discussion will emphasize practical strategies for stakeholders across biotech, healthcare, and policy to effectively bring human-derived innovations to market.
Join us to unpack what truly constitutes “substance” in today’s biotech ecosystem—and how Europe is shaping its future.

Microviable
¿CSL?
¿Arosa I+D?

Imagine a crossroads where human health, animal welfare, and the environment meet — and a new generation of sentinels stands guard. This panel will convene those sentinels to tackle the urgent challenge of protecting vulnerable people and animals from disease driven by major antibiotic‑resistant threats, and to showcase the bleeding‑edge tools that spot and dissect multidrug‑resistant bacteria across clinical, food and environmental landscapes within a One Health framework. We’ll voyage through the knotted realities of vaccine development and market access, then move into the fast‑moving world of diagnostics: gene‑based LAMP assays that turn hours into minutes, electrochemical biosensors that read microbial whispers as electrical signals, nanomaterial‑amplified methods that reveal the faintest traces of pathogens, microfluidic “lab on a chip” platforms that miniaturize whole laboratories, and point‑of‑care systems built for real‑world decisions. The growing appreciation for vaccines—from immune surrogates of protection to fresh insights into host‑pathogen dynamics and sharper disease definitions—will be explored as a keystone for prevention. Recent breakthroughs already sound like science fiction: sub‑hour detection of key AMR genes, ultra‑low limits of detection in messy samples, and real‑time antimicrobial susceptibility testing that brings clinical and research timelines into alignment. These advances not only sharpen bedside decision making but also feed drug discovery with high‑resolution pathogen profiles that accelerate new antimicrobial development. The panel will bring together thought leaders in vaccines, diagnostics, microfluidics, biosensing, environmental microbiology, and pharmaceutical innovation to chart the next frontiers in AMR detection — and to imagine how those frontiers will reshape the hunt for tomorrow’s drugs.


Introduction – The One Health Challenge of MDR Bacteria (5 min)
Block 1 - From Immunity to Impact: Building Executable AMR Vaccines (15 min)
Block 2 – Genetic Detection of MDR Bacteria: LAMP and Other Rapid Molecular Techniques (15 min)
Block 3 – Electrochemical Biosensing: Fast, Sensitive Characterization of MDR Bacteria (15 min)
Block 4 – Point of Care Devices and Lab on a Chip Systems for Rapid AMR Decision-Making (15 min)
Block 5 – Connecting Diagnostics to Drug Development: The Feedback Loop (10 min)