Training & Support Programme
Building
Competence and Capacity for the Implementation of
New Approach Methodologies
(NAMs)
EDUCATE – Interactive Online Training
The EDUCATE programme forms the theoretical
backbone.
Trough our Moodle platform, it offers flexible, expert-led training
for everybody, especially:
- SMEs and start-ups
- Research organisations
- Enterprises
- Regulators and public authorities
Structure of the EDUCATE Programme
1.
Core Introductory Module
This module covers cross-cutting fundamentals,
including:
- What are NAMs?
- Regulatory landscape and acceptance
- Ethics and innovation in NAMs
- Cross-sectoral applications
- Benefits, limitations and implementation potential
2.
Specialised Sub-Modules
Participants select one or more of the
following in-depth modules (15–20 hours each):
- Organ-on-Chip (OoC)
From microfabrication and fluid dynamics to vascularisation, sensor integration, in silico modelling and regulatory frameworks, this module provides a comprehensive scientific and industrial overview. Case studies address pharmaceutical R&D, food safety, regulatory toxicology and personalised medicine. - Organoids
This module focuses on organoid-based in vitro modelling and patient-derived disease models (e.g., Parkinson’s disease, retinal disorders, kidney disease, pancreatic cancer). It includes guidance on experimental design, statistical planning, ethical compliance and future developments such as assembloids. - Digital Twins
Participants receive introductory training in respiratory digital twin models, healthcare data governance, MATLAB-based modelling and machine learning fundamentals. The module bridges mathematical modelling, AI, and regulatory considerations. - Benchtop Simulations /
Bioprinting (MedTech Focus)
This module addresses preclinical evaluation of medical devices, regulatory requirements (EMA, FDA), Good Laboratory Practice (GLP), biocompatibility testing, vascular model validation and imaging technologies for neurovascular devices.
Certification
Participants who pass the final assessment
(≥80%) receive a certificate for each completed module.
Certification is a prerequisite for participation in the ENABLE and APPLY
programmes.
ENABLE – Tailor-Made SME Support
The ENABLE programme translates knowledge into practice. It provides selected SMEs with structured, high-value support to accelerate their NAM implementation strategy.
Who Can Apply?
SMEs meeting EU criteria (<250
employees, defined turnover/balance limits).
Selection
is based on:
- Innovation potential and relevance to NAMs
- Market readiness (TRL level and feasibility)
- Expected impact on growth and competitiveness
- Capacity and motivation to implement outcomes
- Contribution to European NAM ecosystems
The Three ENABLE Support Formats
ENABLE consists of three separate support formats, each with its own application process, allowing SMEs to apply according to their specific needs and interests. It provides structured, practical support to help SMEs overcome scientific, technical and regulatory barriers in NAM adoption.
1. On-site Training at Atlantic Technological
University (Ireland)
Hands-on training focused on medical imaging,
device prototyping and applied NAM use in MedTech, delivered in a real clinical
and technical environment.
- Small-group sessions (approx. 10 SMEs per session)
- Practical one-day training formats
- Access to fluoroscopy suite, 4D ultrasound and technical facilities
2. On-site Training at 3R Center Tübingen
(Germany)
Specialised on-site training on advanced NAM
technologies with a strong focus on regulatory requirements and validation
pathways.
- Microfabrication, microfluidics and biomaterials
- Up to 30 participants per session
- Five half-day training courses across 48 months
3. SME Consulting & One-to-One Support
Individual consulting support tailored to
company-specific challenges in NAM implementation.
- One-to-one mentoring with 3R experts
- Flexible, on-demand scheduling
- Limited to 6 SMEs
- Support covering status analysis, model selection and implementation planning
- Consulting support of up to €22,000 per SME in specific formats
APPLY – Challenge-based NAM implementation
The APPLY programme is a challenge-based competition designed to foster SME–industry collaboration and accelerate real-world NAM implementation.
Concept
Large and mid-sized BioPharma and MedTech companies act as Challenge Providers. The challenges are published through open calls, allowing SMEs to apply to the challenge(s) that match their expertise and technology focus. Selected SMEs co-develop solutions together with the Challenge Provider, addressing concrete industrial needs and advancing NAM implementation towards market readiness.
Who Can Apply?
- Completion of an EDUCATE module
- Minimum TRL 4
- Dedicated team capacity (0.5–2 FTE)
- Strong innovation and execution capability
What Selected SMEs Receive
- Four months of structured mentoring
- A dedicated training package (valued at €3,000 per SME)
- On-site collaboration with the Challenge Provider (travel voucher included)
- Opportunities to connect with investors and manufacturers
- Visibility at final dissemination events and European innovation platforms
Why
Participate?
The STEP4NAMs Training & Support Programme
offers more than theoretical training. It
provides:
- Scientifically rigorous, expert-led education
- Direct pathways to implementation
- Regulatory and industrial insights
- Structured SME support
- Access to a transnational innovation ecosystem
- Opportunities for industrial co-development
For SMEs, researchers and institutions aiming to advance the use of NAMs in BioPharma and MedTech, STEP4NAMs provides a coherent, practice-oriented framework to move from knowledge acquisition to validated application.