guideSkin · Bridging regulatory science and innovation for dermal generics and advanced skin therapies
„Хоризонт Европа“ — Действия „Мария Склодовска-Кюри“
- Период
- 2026-10-01 → 2030-09-30
- Финансиране от ЕС
- 4 626 203 €
- Участници
- 19
- Схема
- HORIZON-TMA-MSCA-DN-ID
Линиите свързват координатора с партньорите. За проекти отпреди 2014 г. CORDIS не винаги дава точни координати. Тези точки са на ниво град или държава.
Накратко на български
Новите методи за анализ на лекарства за кожата, като AI моделиране и лазерна спектроскопия, помагат за по-бързото одобрение на генерични продукти и микроигли. Това ще улесни достъпа на пациентите до качествени терапии и ще намали забавянията при пускането им на пазара.
Кратко обяснение, генерирано от езиков модел по текста на CORDIS. Оригиналът е по-долу.
Цел на проекта
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.
Оригинален текст от CORDIS (на английски).
Участници
- EBERHARD KARLS UNIVERSITAET TUEBINGEN · TuebingenКоординаторГермания
- ACCELOPMENT SCHWEIZ AG · ZurichШвейцария
- Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V. · MainzНиво градГермания
- Dermapharm Holding SE · GrünwaldНиво градГермания
- ESQLABS GMBH · SATERLANDГермания
- FARMACEUTSKI FAKULTET UNIVERZITETA U BEOGRADU · BELGRADEСърбия
- Faculdade de Farmácia da Universidade de Lisboa · LisboaПортугалия
- GIE LVMH RECHERCHE · SAINT JEAN DE BRAYEФранция
- Galenika a.d. · BeogradНиво градСърбия
- LTS Lohmann Therapie-Systeme AG · AndernachНиво градГермания
- Phardevelopment Trials, lda · ColaresНиво градПортугалия
- RIVERD INTERNATIONAL BV · RotterdamНидерландия
- RaDes GmbH · HamburgНиво градГермания
- Tiofarma BV · Oud BeijerlandНиво градНидерландия
- UNILEVER U.K. CENTRAL RESOURCES LIMITED · LONDONОбединеното кралство
- UNIVERSITE PARIS-SACLAY · Gif-Sur-YvetteФранция
- UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK · CorkИрландия
- UNIVERSITY OF SURREY · GuildfordОбединеното кралство
- proderm GmbH · SchenefeldНиво градГермания
Връзки
Данни: CORDIS, © Европейски съюз