Unravelling the Regulatory Roadmap for Allogeneic Products to Pave the Route to Commercial Success

Time: 9:31 am
day: Pre-Conference Day


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


• 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