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Actors and Networks database

The evolving field of gene and cell therapy is supported by a large community of academic, clinical, translational, regulatory and patient organisations. The Actors and Networks database maps these stakeholders in Europe and beyond, their activities, and resources they have produced. 

EuroGCT has developed and compiled this database for those interested in identifying the actors involved at each stage of the pathways bringing gene and cell therapies from lab to clinic. Coming from an academic perspective, our focus is to map information that has not been mapped elsewhere. This includes documenting the various types of interconnected regulators, patient groups actively involved along the pathways, and non-profit organisations devoted to therapy development. In its first iteration, this database does not yet include commercial partners and service providers.

Additional complementary work by other organisations on GCT stakeholders mapping can be found here.

A scientific paper on actors has also been published in Humanities and Social Sciences Communications. You can find its lay summary here.

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Dutch Gene Therapy Office (Loket Gentherapie)

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

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Dutch Healthcare and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd) (IGJ)

Region/Country:  
  • Countries in the EU/EEA
  • Netherlands
Website:  

Type of Actor:

  • Regulators
  • 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

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Dutch Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) (MEB / CBG)

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

Type of Actor:

  • Regulators
  • Medicines Agencies
  • National Medicines Agencies
  • Other National competent authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Dutch Ministry of Health, Welfare and Sports (Ministerie van Volksgezondheid, Welzijn en Sport) (VWS)

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

Type of Actor:

  • Regulators
  • 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

Development Stage:

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

Dutch Ministry of Infrastructure and Water Management (Ministerie van Infrastructuur en Waterstaat)

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

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Resources

Ressources: OGM – Les autorités compétentes (in french) : https://ogm.public.lu/fr/controles-officiels/les-autorites-competentes.html

Dutch National Health Care Institute – (Zorginstituut Nederland – National Health Care Institute) (ZIN)

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

Type of Actor:

  • Regulators
  • HTA Bodies

Development Stage:

  • Commercialisation

Dutch National Institute for Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu)

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

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

EATRIS CONNECT Project

Region/Country:  
  • EU/EEA

Type of Actor:

  • Networks
  • EU Research Projects

Development Stage:

  • Translational Research

Additional information

EATRIS is the European Infrastructure for Translational Medicine; a non-profit organisation that brings together resources and services for research communities to translate scientific discoveries into benefits for patients. EATRIS focuses on improving and optimising preclinical and early clinical development of drugs, vaccines and diagnostics, and overcoming barriers to health innovation. EATRIS-CONNECT is an EU-funded initiative that will use digital transformation as a tool to accelerate translational medicine.

ENTE Certificazione Macchine SRL

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

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Notified Bodies

Development Stage:

  • Manufacturing
  • Commercialisation

Estonia State Agency of Medicines (Ravimiamet)

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

Type of Actor:

  • Regulators
  • 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

The Estonia State Agency of Medicines is a governmental body under the Ministry of Social Affairs. Its main responsibility is the protection and promotion of public and animal health, through the supervision of medicines for human and veterinary use.
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