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Database Attori e Reti

Il campo in continua evoluzione della terapia genica e cellulare è sostenuto da un’ampia comunità di organizzazioni accademiche, cliniche, traslazionali, regolatorie e di pazienti. Il Attori e reti mappa questi soggetti interessati in Europa e oltre, le loro attività e le risorse che hanno prodotto.

EuroGCT ha sviluppato e compilato questo database per coloro che desiderano identificare gli attori coinvolti in ciascuna fase dei percorsi che portano le terapie geniche e cellulari dal laboratorio alla clinica. Provenendo da una prospettiva accademica, il nostro obiettivo è quello di mappare informazioni che altrove non sono state documentate. Ciò include la descrizione dei vari tipi di autorità regolatorie interconnesse, dei gruppi di pazienti attivamente coinvolti lungo i percorsi e delle organizzazioni non a scopo di lucra dedicate allo sviluppo di nuove terapie.

In questa prima versione, il database non include ancora partner commerciali e fornitori di servizi.
Ulteriori lavori complementari sul mappaggio degli stakeholder nel campo delle terapie geniche e cellulari, condotti da altre organizzazioni, possono essere consultati qui.

Un articolo scientifico sugli attori è stato inoltre pubblicato su Humanities and Social Sciences Communications. È disponibile anche qui un riassunto divulgativo.

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3EC International a.s.

Region/Country:  
  • Countries in the EU/EEA
  • Slovakia

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Notified Bodies

Development Stage:

  • Manufacturing
  • Commercialisation

Action Duchenne

Region/Country:  
  • EU/EEA

Type of Actor:

  • Patient Organisations
  • Regional/Local Patient Organisations

Development Stage:

  • Patient and Public Involvement

Conditions and Diseases:

  • Muscle and Skeletal Diseases
  • Rare diseases

Additional information

Action Duchenne is a charity that supports families and individuals affected by Duchenne muscular dystrophy (DMD), a rare and progressive muscle-wasting condition.

Advanced Therapy Treatment Centre (ATTC)

Region/Country:  
  • UK

Type of Actor:

  • Networks
  • European and Regional Networks
  • Non-profit Research Organisations
  • National Research Centres
  • Research Hospitals

Development Stage:

  • Clinical Research
  • Translational Research
  • Manufacturing
  • Commercialisation

Additional information

The ATTC network is a UK wide group of Advanced Therapy Treatment Centres operating within the NHS framework. It aims to address the unique and complex challenges of bringing pioneering advanced therapy medicinal products (ATMPs) to patients.

AFM-Téléthon

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Patient Organisations
  • Regional/Local Patient Organisations

AFNOR Certification

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Notified Bodies

Development Stage:

  • Manufacturing
  • Commercialisation

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (Javna agencija Republike Slovenije za zdravila in medicinske pripomočke) (JAZMP)

Region/Country:  
  • Countries in the EU/EEA
  • Slovenia

Type of Actor:

  • Regulators
  • HTA Bodies
  • Medicines Agencies
  • National Medicines Agencies
  • Medical Devices Entities
  • Medical Device Authorities
  • National Medical Device Authorities
  • Other National competent authorities
  • Competent Authorities for Tissues and Cells
  • Competent Authorities for Blood and Blood Components
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

According to the JAZMP Website: “In the Republic of Slovenia, HTA is currently not performed in a dedicated HTA institution. JAZMP is currently not an HTA competent authority, but is in the position to perform HTA-related tasks in pricing procedures as defined in Article 182 of the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 and 66/19).” (https://www.jazmp.si/en/human-medicines/health-technology-assessment/)

All Wales Therapeutics and Toxicology Centre (AWTTC)

Region/Country:  
  • UK

Type of Actor:

  • Regulators
  • HTA Bodies

Development Stage:

  • Commercialisation

Alliance for Regenerative Medicine (ARM)

Region/Country:  
  • Global

Type of Actor:

  • Networks
  • Other International Networks

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Translational Research
  • Manufacturing
  • Commercialisation

Additional information

ARM is an international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM represents the interests of 400+ members across 25 countries, including small and large companies, academic research institutions, major medical centers and patient groups.

Amgros

Region/Country:  
  • Countries in the EU/EEA
  • Denmark

Type of Actor:

  • Regulators
  • HTA Bodies

Development Stage:

  • Commercialisation

Association of the British Pharmaceutical Industry (ABPI)

Region/Country:  
  • UK

Type of Actor:

  • Networks
  • European and Regional Networks

Development Stage:

  • Clinical Research
  • Translational Research
  • Manufacturing
  • Commercialisation
  • Patient and Public Involvement

Additional information

The Association of the British Pharmaceutical Industry is the trade association for over 120 companies in the UK producing prescription medicines for humans