Hot Topic Session - ICH Cell & Gene Therapy Discussion Group Updates

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and representatives from the pharmaceutical industry from across the globe to discuss a range of technical and scientific considerations for medicinal products and to develop ICH guidance. In this manner, ICH provides a harmonized approach to ensure that safe, effective and high-quality medicines are developed, registered, and maintained in a resource efficient manner whilst meeting high standards. As cell and gene therapy products have become ever more prevalent in the therapeutic landscape, the specific considerations applicable to such products are in need of specific recommendations for revisions to existing ICH guidelines and/or new guideline development. The ICH Cell and Gene Therapies Discussion Group (CGT DG) has been formed, and the Remit was endorsed by the ICH Management Committee in May 2023. In this session we will hear about the scope of ICH CGT DG activities and their progress toward targeted deliverables. 

Session Speaker:

ICH CGT DG: Progress Toward Delivering a Strategic Roadmap for ATMPs

Kathleen Francissen, Genentech, A Member of the Roche Group

Additional Panelist:

Melanie Eacho, CBER, FDA