CellCAN annonce le webinar (diffusé en anglais):
21 novembre 2019, 12h : lien pour se connnecter
Extraneous Considerations for Cell and Gene Therapy Manufacturing with Dr. David Courtman, from the Ottawa Hospital Research Institute
The translation of cell therapies from basic research to clinical trials requires the development of standard operating processes that are both regulatory compliant and of relatively low risk to the quality of the final product. This often requires the careful external sourcing of ancillary materials and services. An appropriate risk analysis needs to be performed to identify and mitigate the risks involved from external suppliers. In early phase trials this may simply involve document review, development of contractual/reporting arrangements, and implementation of an incoming product qualification strategy. As trials progress to later phases external site visits and complete audits may need to be performed to assure the continuous supply of high-quality goods and services. I will draw on examples from past academic trials to highlight our experience in implementing these strategies from first in man safety trials to larger efficacy-based studies.