Unravelling the Regulatory Roadmap for Allogeneic Products to Pave the Route to Commercial Success
Time: 9:31 am
day: Pre-Conference Day
Details:
Having a clear understanding of current regulations for preclinical, clinical and CMC
is essential in the progression of your allogeneic products and therapies. In this
regulatory workshop hear about new regulations and changes from experts from
regulatory bodies across Europe and have your burning questions answered by these
key players.
This workshop will cover:
• Recent guideline changes in Europe to inform on clinical trial design and data
requirements
• How new cell and gene therapy comparability guidelines may impact process
changes during development
• Global differences in data requirements for the transition from preclinical to clinical
trials
