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Klinische studie

  • 07-01-2026

    Advice Update on prerequisites for generic environmental risk assessment of clinical studies and marketing applications involving ex vivo retro- and lentiviral transduced cells

    Update of prerequisites for clinical studies involving transduced cells.

    Advisory reports
    CGM/251127-01 View more
  • 14-05-2025

    Joint open letter COGEM and ZKBS on the ERA of new vaccine developments based on samRNAs and VRPs

    In this Joint open letter to the European Commission, the Netherlands Commission on G...

    Policy reports
    CGM/250514-01 View more
  • 20-08-2021

    Advice following the European consultation on the authorisation process of GMOs in medical applications

    The Ministry of Infrastructure and Water Management has asked COGEM whether an enviro...

    Advisory reports
    CGM/210820-01 View more
  • 07-05-2020

    Generic environmental risk assessment of gene therapies that use GM cells containing free lentiviral particles

    A generic environmental risk assessment has been prepared for gene therapy trials in ...

    Advisory reports
    CGM/200507-01 View more
  • 11-02-2020

    Generic environmental risk assessment of clinical trials with AAV vectors

    Hundreds of clinical trials have been carried out worldwide in which use was made of ...

    Advisory reports
    CGM/190905-01 View more
  • 04-09-2015

    Research report Assessment of preclinical gene therapy studies worldwide

    Frequently, the success of preclinical gene therapy studies in animal models is repor...

    Research reports
    CGM 2015-03 View more
  • 12-01-2011

    Replication-competent non-human viruses for use in clinical gene therapy: an inventory study

    All living organisms are exposed to viruses. In general, viruses infect only a single...

    Research reports
    CGM 2010-10 View more