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Session 2: A Panel Discussion on Global Regulatory Guidance and Harmonization in Cell and Gene Therapy
Session Chair(s)
Maria Vassileva, PhD
Chief Science and Regulatory Officer
DIA, United States
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.
Learning Objective : - Differentiate global harmonization efforts and understand the role of international collaboration in approval pathways
- Evaluate the impact of recent global regulatory guidance on cell and gene therapy development
- Identify key regulatory challenges in balancing safety, efficacy, and efficiency
Speaker(s)
Speaker
Peter W. Marks, MD, PhD
DIA Fellow, United States
Speaker
Representative Invited
ANVISA, Brazil
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