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The Cell and Gene Therapy Products (CGTP) Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products…
Analytics for Process-related Impurities in Viral Vector Manufacturing
Several cell and gene therapy products have received marketing approval from health authorities and, with that, a more complete picture is now emerging about the regulatory CMC requirements to commercialize these products…
With the recent approval of several Adeno-Associated Virus (AAV)-based gene therapies, the application of AAV gene therapy approaches to the treatment of human disease is expanding…
Bringing treatment to those afflicted with an ultra-rare disease is complex. These products are encumbered with challenges ranging from high development costs with a limited ROI, to issues with executing and interpreting clinical trials with unusually small patient populations…