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 

 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

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

translational    manufacturing    medicinal    academic    facilities    therapy    industrial    analysing    regulation    cgmp    designed    health    good    ec    medicines    standards    atmps   

 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.

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