ACADEMIC GMP

The impact of Regulation (EC) No 1394/2007 on the development of Advanced Therapy Medicinal Products (ATMPs): an academic perspective

Coordinatore	KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN    more  Organization address address: ISMANINGER STRASSE 22 city: MUENCHEN postcode: 81675 contact info Titolo: Ms. Nome: Renate Cognome: Rädlein Email: send email Telefono: +49 89 41402842 Fax: +49 89 41404926
Nazionalità Coordinatore	Germany [DE]
Totale costo	557˙520 €
EC contributo	498˙747 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2010-single-stage
Funding Scheme	CSA-SA
Anno di inizio	2010
Periodo (anno-mese-giorno)	2010-09-01   -   2013-05-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN  Organization address address: ISMANINGER STRASSE 22 city: MUENCHEN postcode: 81675 contact info Titolo: Ms. Nome: Renate Cognome: Rädlein Email: send email Telefono: +49 89 41402842 Fax: +49 89 41404926	DE (MUENCHEN)	coordinator	82˙390.00
2	UNIVERSITY OF NEWCASTLE UPON TYNE  Organization address address: Kensington Terrace 6 city: NEWCASTLE UPON TYNE postcode: NE1 7RU contact info Titolo: Ms. Nome: Aleona Cognome: Blinova Email: send email Telefono: +44 0191 282 4528 Fax: +44 0191 282 4524	UK (NEWCASTLE UPON TYNE)	participant	161˙570.00
3	MEDIZINISCHE HOCHSCHULE HANNOVER  Organization address address: Carl-Neuberg-Strasse 1 city: HANNOVER postcode: 30625 contact info Titolo: Mr. Nome: Frank Cognome: Dittrich Email: send email Telefono: +49 511 532 5343 Fax: +49 511 532 4253	DE (HANNOVER)	participant	114˙743.42
4	KLINIKUM DER UNIVERSITAET REGENSBURG  Organization address address: FRANZ JOSEF STRAUSS ALLEE 11 city: REGENSBURG postcode: 93053 contact info Titolo: Ms. Nome: Elisabeth Cognome: Geiger Email: send email Telefono: +49 941 944 5785 Fax: +49 941 944 5899	DE (REGENSBURG)	participant	34˙133.00
5	MEDIZINISCHE UNIVERSITAET WIEN  Organization address address: SPITALGASSE 23 city: WIEN postcode: 1090 contact info Titolo: Prof. Nome: Christoph Cognome: Zielinski Email: send email Telefono: +43 1 404 004 457 Fax: +43 1 404 002 511	AT (WIEN)	participant	34˙133.00
6	UNIVERSITY COLLEGE LONDON  Organization address address: GOWER STREET city: LONDON postcode: WC1E 6BT contact info Titolo: Ms. Nome: Kay Cognome: Tott Email: send email Telefono: +44 20 7679 6700 Fax: +44 20 7679 6700	UK (LONDON)	participant	29˙318.00
7	LUNDS UNIVERSITET  Organization address address: Paradisgatan 5c city: LUND postcode: 22100 contact info Titolo: Ms. Nome: Hanna Cognome: Barjosef Email: send email Telefono: +46 462220462 Fax: +46 462223600	SE (LUND)	participant	21˙935.00
8	IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY AND MEDICINE  Organization address address: SOUTH KENSINGTON CAMPUS EXHIBITION ROAD city: LONDON postcode: SW7 2AZ contact info Titolo: Ms. Nome: Palalic Cognome: Tatjana Email: send email Telefono: +44 208 383 2241 Fax: +44 208 383 3237	UK (LONDON)	participant	19˙260.00
9	KLINIKUM DER JOHANN WOLFGANG VON GOETHE UNIVERSITAET  Organization address address: Theodor Stern Kai 7 city: FRANKFURT AM MAIN postcode: 60590 contact info Titolo: Ms. Nome: Kseniya Cognome: Polozheyeva Email: send email Telefono: +49 696 3016848 Fax: +49 696 301 81089	DE (FRANKFURT AM MAIN)	participant	1˙264.58

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 Obiettivo del progetto (Objective)

'Advanced Therapy Medicinal Products (ATMPs) are medicinal products for human use, based on gene therapy, somatic cell therapy or tissue engineering. A rapidly growing area in translational research, they represent the ‘next generation’ of complex medicines for complex diseases and pose particular challenges to medicines regulation. Regulation (EC) No 1394/2007 has been designed to ensure the free movement of ATMPs within the European Union (EU), to facilitate their access to the EU market and to foster the competitiveness of European pharmaceutical companies while guaranteeing the highest level of health protection for patients. The regulation extends standards of current Good Manufacturing Practice (cGMP) to ATMPs to ensure their quality, safety and efficacy. Academic cGMP facilities are major contributors to the development of ATMPs. They respond to clinical needs and provide medicinal products in an environment which, albeit compliant with industrial standards, is by definition not industrial. They find themselves in a challenging position between various, sometimes conflicting interests in the transition of ATMPs from bench to bedside. European investigator-initiated multicenter trials on ATMPs critically depend on academic cGMP facilities. We will assess the impact of Regulation (EC) No 1394/2007 on academic cGMP facilities by: a) conducting a European survey among non-industry facilities in this sector; b) organising workshops and a major conference for targeted, collaborative discourse; c) establishing a web-based platform for information exchange; d) analysing publications and guidance from the perspective of better regulation principles; e) analysing innovation statistics in relation to ATMPs. These activities will yield comprehensive evidence and concrete suggestions to policy makers. The project will in itself foster a dialogue that will strengthen networks of translational research and thus contribute to research excellence in Europe.'

Introduzione (Teaser)

Technological advances in the field of biology and translational research have led to a new era of therapeutic modalities. As most of these approaches are designed and developed in academic institutes, the EU needs to ensure that good manufacturing practice (GMP) health standards are maintained.