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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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BSI Group The Netherlands B.V.

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

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Notified Bodies

Development Stage:

  • Manufacturing
  • Commercialisation

Bulgarian Commission for Personal Data Protection (Комисия за защита на личните данни) (CPDP)

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

Type of Actor:

  • Regulators
  • Data Authorities
  • National Data Authorities

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Translational Research
  • Health Data

Bulgarian Drug Agency (Изпълнителна агенция по лекарствата) (BDA)

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

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 Blood and Blood Components
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The BDA is the national medicines agency and the competent authority for blood and blood components in Bulgaria

Bulgarian Executive Agency "Medical Supervision" (Изпълнителна агенция „Медицински надзор“) (IAMN / ИАМН)

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

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Tissues and Cells

Development Stage:

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

Additional information

The Bulgarian Executive Agency for Transplantation (BEAT) is the competent authority for management, coordination and control of transplantation of organs, tissues and cells in Bulgaria

Bulgarian Ministry of Environment and Water (Министерството на околната среда и водите) (MoEW)

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

Type of Actor:

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

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Bulgarian National Center of Public Health and Analyses (Национален Център по Обществено Здраве и Анализи) (NCPHA / НЦОЗА)

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

Type of Actor:

  • Regulators
  • HTA Bodies

Development Stage:

  • Commercialisation

Bulgarian National Council on Prices and Reimbursement of Medicinal Products (Национален Съвет по Цени и Реимбурсиране на Лекарствените Продукти) (NCPR / НСЦРЛП)

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

Type of Actor:

  • Regulators
  • HTA Bodies

Development Stage:

  • Commercialisation

Bureau Veritas Italia S.P.A.

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

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Notified Bodies

Development Stage:

  • Manufacturing
  • Commercialisation

Caring Cross

Region/Country:  
  • USA

Type of Actor:

  • Networks
  • Other International Networks

Development Stage:

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

Additional information

Caring Cross aims to accelerate the development of advanced medicines and ensure access for ALL patients by organizing and supporting a community of healthcare professionals, scientists and engineers, community advocates and business leaders.

Resources

CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.

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

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Notified Bodies

Development Stage:

  • Manufacturing
  • Commercialisation
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