Cell and Gene Therapy Summit

Global regulatory frameworks have evolved in tandem with the rapid advancements in cell and gene therapies. This session will review the latest regulatory guidance documents from global regulatory agencies and identify strategies that have been used to address key challenges in the field, such as protecting patient safety and product efficacy. Given the need for efficiency in a fast-moving landscape yet a balance of regulatory rigor, panelists will draw attention to how existing regulatory frameworks have adapted to the increase of cell and gene therapies and recent opportunities for global harmonization of regulatory processes. The session will highlight examples of international collaboration, how approval pathways have been streamlined, and regulatory trends that are molding the future of cell and gene therapy.