The STEP4NAMs Training & Support Programme is a comprehensive capacity-building initiative designed to accelerate the adoption in the BioPharma and MedTech sectors.
The programme equips stakeholders across the value chain with the scientific knowledge, technical skills and strategic guidance necessary to implement NAMs effectively and sustainably. The programme is structured into three complementary pillars:
- EDUCATE – Interactive Online Training
- ENABLE – Tailor-Made SME Support
- APPLY –Chlallenge-based NAM implementation
Together, these pillars provide a pathway from foundational knowledge to practical implementation and industrial collaboration.
Learn more about the programme at our Information webinar
We were very pleased about the strong interest in our STEP4NAMs webinar. A large number of participants from
research, industry and other life sciences fields registered to learn
more about the upcoming training and support programme on New Approach Methodologies (NAMs).
The high level of engagement during the session was particularly
encouraging – the many questions and contributions from the audience
clearly showed the growing interest in practical training and the
application of innovative approaches such as organ-on-chip, organoids
and digital models. We would like to sincerely thank all participants
for their active participation and thoughtful questions.
For those who
could not join the webinar live, or who would like to revisit the
content, the recording is available now: About the Webinar
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
The core module is already fully available: Read more
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
The Sub-Modules will be available soon.
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 the use of patient-derived organoids for disease modelling. It introduces key approaches for organoid generation and culturing, highlights their advantages, limitations and applications across biomedical research and industry and demonstrates their potential to mimic human organs. The module also covers experimental design, statistical planning, ethical and GDPR compliance and future developments such as more complex organoid models including 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.
Bench-Top Simultion Systems
This module covers the various types of tests performed during the pre-clinical evaluation of medical devices at different development stages, with particular emphasis on regulatory requirements from agencies such as the EMA and FDA. Special focus is given to the validation of bench-top testing systems used to assess 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
introducing organ-on-chip technology, microfluidics, and biomaterials.
- 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.
Who can apply?
- Completion of an EDUCATE module
- Minimum TRL 4
- Dedicated team capacity (0.5–2 FTE)
- Strong innovation and execution capability
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.
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.
.
.