STARS · Project

Pan-European Regulatory Training to Get Treatments Approved Faster

healthPilotedTRL 7Thin data (2/5)

Imagine you've spent years developing a promising new treatment, but when you try to get it approved, you hit a wall of regulatory requirements nobody taught you about. That's what happens to a lot of academic researchers — they know the science but not the rules of the approval game. STARS brought together regulators from 17 European countries to build standardized training programs so researchers learn these rules early, before they waste years going down the wrong path. Think of it like a driving school for the drug approval highway.

By the numbers

European countries represented through national competent authorities

consortium partners

countries in the consortium

pilot programs implemented and evaluated

1,986,000

EUR in EU contribution

The business problem

What needed solving

Promising medical treatments frequently fail or face costly delays at the regulatory approval stage — not because the science is bad, but because researchers lack training in regulatory requirements. This knowledge gap means companies invest years and millions into products that hit avoidable roadblocks when they reach regulators. The problem is compounded across Europe where 17+ national agencies each have their own procedures and expectations.

The solution

What was built

STARS produced a Comprehensive Inventory of existing regulatory training programs across Europe, a Common Strategy for strengthening regulatory sciences, two standardized curricula (a Core Curriculum for clinical scientist training and a Comprehensive Curriculum for post-graduate programs), and tested all three through dedicated pilot implementations with analysis reports.

Audience

Who needs this

Pharma companies with drug candidates in late preclinical or early clinical stagesBiotech startups preparing first regulatory submissionsContract research organizations offering regulatory strategy servicesMedical device companies entering new European marketsUniversity hospitals running translational research programs

Business applications

Who can put this to work

Pharmaceuticals

enterprise

Target: Pharma companies with drug candidates approaching regulatory submission

If you are a pharma company losing months or years to regulatory rejections and rework — this project developed standardized regulatory science curricula piloted across 17 European countries. These training programs were designed to close the knowledge gap between lab results and regulatory approval, helping your R&D teams anticipate requirements from the start rather than discovering them at submission time.

Biotechnology

SME

Target: Biotech startups navigating first-time regulatory approval

If you are a biotech startup preparing your first regulatory submission and don't have in-house regulatory expertise — STARS created a Core Curriculum specifying essential regulatory knowledge for clinical scientists. The project's 3 pilot programs tested practical training approaches that could help your team understand what regulators expect before you invest in a costly submission process.

Contract Research

mid-size

Target: CROs offering regulatory consulting services

If you are a contract research organization looking to differentiate your regulatory advisory services — STARS produced a Comprehensive Inventory of existing regulatory support activities across 18 countries and identified gaps. Their Common Strategy and curricula, validated through 3 pilots with 21 consortium partners, provide a structured knowledge base you could integrate into your client advisory offerings.

Frequently asked

Quick answers

What would it cost to access the STARS training curricula?

STARS was a Coordination and Support Action funded with EUR 1,986,000 in EU contribution. The curricula and recommendations developed are public outputs. Licensing costs are not indicated — contact the coordinator (BfArM, Germany) for specific terms of use or adaptation rights.

Can these training programs scale to a large pharmaceutical organization?

The project was designed for pan-European scale from the start, involving 21 partners across 18 countries. The Comprehensive Curriculum was piloted as a full implementation (Pilot III), and the best-practice transfer model (Pilot I) was specifically tested for replication across EEA countries. This suggests the materials are built for cross-border adoption.

Is there any IP or licensing involved?

As a publicly funded CSA (Coordination and Support Action), the project outputs — curricula, inventories, and recommendations — are generally intended for broad dissemination. Based on available project data, no patents or proprietary licensing structures are indicated. Contact BfArM for formal usage terms.

How does this help with specific regulatory submissions?

STARS developed a support activity (Pilot II) specifically aimed at improving success rates on regulatory Scientific Advice — the formal process where regulators guide companies before submission. This directly addresses the most common failure point where promising treatments stall due to misaligned regulatory expectations.

When were the pilots completed and are results available?

The project ran from January 2019 to June 2022 and is now closed. All 3 pilot implementation reports were delivered as project deliverables. Results and recommendations should be accessible through the project website at csa-stars.eu or through the coordinator.

Which regulatory agencies were involved?

The consortium included national competent authorities from 17 European countries, coordinated by BfArM (the German Federal Institute for Drugs and Medical Devices). This gives the outputs direct credibility with the agencies that actually make approval decisions across the EEA.

Consortium

Who built it

The STARS consortium is heavily institutional — 21 partners across 18 countries with zero industry participants and zero SMEs. The consortium is built around 6 research organizations and 15 other entities (primarily national regulatory agencies and academic bodies). This is typical for a Coordination and Support Action aimed at policy and training rather than product development. For businesses, the key takeaway is that this project had direct buy-in from the regulators who make approval decisions, which gives its curricula and recommendations unusual authority. The coordinator, BfArM, is Germany's federal drug and medical device regulator — not an academic institution but a decision-making body.

BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTECoordinator · DE
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCYparticipant · UK
AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOSparticipant · ES
BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTELparticipant · DE
NEMZETI NEPEGESZSEGUGYI ES GYOGYSZERESZETI KOZPONTparticipant · HU
AGES - OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBHparticipant · AT
LAAKEALAN TURVALLISUUS-JA KEHITTAMISKESKUSparticipant · FI
DEUTSCHES ZENTRUM FUR LUFT - UND RAUMFAHRT EVparticipant · DE
HEALTH PRODUCTS REGULATORY AUTHORITYparticipant · IE
LAKEMEDELSVERKETparticipant · SE
AGENZIA ITALIANA DEL FARMACOparticipant · IT
AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELENparticipant · NL
INFARMED - AUTORIDADE NACIONAL DO MEDICAMENTO E PRODUTOS DA SAUDE IPparticipant · PT
FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTSparticipant · BE
THE EUROPEAN MEDICINES AGENCYparticipant · NL

How to reach the team

Coordinator is BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), Germany's federal drug and medical device regulatory agency. Use SciTransfer's coordinator lookup service to find the right contact person.

Order a report on this consortium See BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE profile →

Next steps

Talk to the team behind this work.

Want to know how STARS regulatory training resources could accelerate your approval process? SciTransfer can connect you with the project team and help you assess which curricula fit your needs.

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