Gathering Health Authority Feedback
This workstream aims to create a tool for the gathering and interegation of health authority feedback related to CGT development projects.
It is challenging to maintain awareness of regulatory expectations with regards to CGT development projects
A current challenge in the CGT industry (including RNA) lies in the inadequate leverage and sharing of health authority feedback (HAF) related to CMC information for CGT development projects.
Industry lacks an easily accessible tool or mechanism to facilitate efficient knowledge sharing and collaboration between companies and benefit from the collective wisdom of HAs. This leads to a potential mismatch between evolving expectations and established guidelines, creating uncertainty and additional burdens for CGT members seeking regulatory approval.
Reduced risk of quality/regulatory non-compliance leading to reduced risk of regulatory delay and delays to market
To design and implement a comprehensive solution to enable CGT members to access and share relevant health authority feedback pertaining to CMC for CGT & RNA development projects. Health authority feedback may originate from HA requests for information, responses to advice questions, HA question and answer documents, and HA town halls, etc. All modalities and all regions are in scope.
Gathering Health Authority Feedback deliverables
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Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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