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Bridging regulatory science and innovation for dermal generics and advanced skin therapies

Objective

Skin diseases affect 900 million people worldwide and impose major physical, psychological, social and emotional burdens, making cutaneous drug products essential to public health.
guideSkin is an Industrial Doctorate training 15 doctoral candidates to transform the development, evaluation and regulatory approval of cutaneous drug products in line with the new EMA Guideline on Quality and Equivalence of Cutaneous Products (effective 2025). The guideline enables bioequivalence-based approval of dermal generics but requires advanced analytical and in vitro methods that many companies and regulators are not yet equipped to apply, causing delays in market entry, reduced innovation and a shortage of specialists able to interpret complex formulation and skin-interaction data.
guideSkin brings together six European universities with key pharma manufacturers and technology-driven industry and SMEs. We will develop a practical, science-based framework for formulation characterisation; advance key permeation-kinetics methods incl. confocal Raman spectroscopy (CRS), physiologically based pharmacokinetic (PBPK) modelling and AI-enabled prediction; and establish quality-evaluation strategies for innovative products such as microneedle array patches (MAPs) and nano-enabled formulations.
Through long-term industrial secondments, interdisciplinary coursework, transferable-skills training and hands-on work in advanced facilities, DCs will gain expertise spanning pharmaceutical technology, spectroscopy, modelling, data and regulatory science. We will deliver validated test protocols, decision trees and computational tools that support regulatory submissions and efficient product development.
guideSkin will strengthen Europe’s innovation capacity and enable faster approval of high-quality dermal medicines and generics. Our graduates will be highly employable specialists able to shape future regulatory frameworks and drive competitiveness in Europe’s pharma and skin-health sectors.

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-TMA-MSCA-DN-ID - HORIZON TMA MSCA Doctoral Networks - Industrial Doctorates

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Call for proposal

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(opens in new window) HORIZON-MSCA-2025-DN-01

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Coordinator

EBERHARD KARLS UNIVERSITAET TUEBINGEN
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 870 816,96
Address
GESCHWISTER-SCHOLL-PLATZ
72074 Tuebingen
Germany

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Region
Baden-Württemberg Tübingen Tübingen, Landkreis
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

No data

Participants (5)

Partners (13)