Streamlining GMO Applications in Clinical Trials: Global Framework and Strategic Considerations
Published on: May 27th, 2025
This webinar provides an overview of key regulatory and strategic considerations for clinical trials involving investigational medicinal products consisting of or containing genetically modified organism (GMO-IMPs), such as gene therapies, viral vector-based vaccines, genetically modified bacteria, etc.
Topics include:
- The presentation of regulatory frameworks (EU, US, UK, Switzerland)
- The building of an efficient submission strategy and associated required data set
- Recommendations regarding collaboration with sites, vendors, and regulatory authorities to support compliance and reduce potential delays
It will give insights for regulatory and clinical development professionals acting as decision makers/key stakeholders, who want to understand the challenges related to GMO applications.
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Streamlining GMO Applications in Clinical Trials: Global Framework and Strategic Considerations
23/6/20255:00pm CEST1 hour
This webinar provides an overview of key regulatory and strategic considerations for clinical trials involving investigational medicinal products consisting of or containing genetically modified organism (GMO-IMPs), such as gene therapies, viral vector-based vaccines, genetically modified bacteria, etc.Topics include:
- the presentation of regulatory frameworks (EU, US, UK, Switzerland)
- the building of an efficient submission strategy and associated required data set
- recommendations regarding collaboration with sites, vendors, and regulatory authorities to support compliance and reduce potential delays.
It will give insights for regulatory and clinical development professionals acting as decision makers/key stakeholders, who want to understand the challenges related to GMO applications.
