Delving into Regulatory Guidelines to Gain Clarity on Requirements for Data, Animal Models, Clinical Considerations, & Safety, to Plan Accordingly
Time: 12:02 pm
day: Pre-Conference Workshop Day
Details:
As this space develops towards the clinic, it’s essential to crystallize regulatory guidelines so companies can align their work with what is required by agencies, thereby streamlining pipelines for a smooth transition from pre-clinical to clinical trials. However, as the field is still emerging, it is imperative to unite efforts to stay ahead of regulatory ambiguities and ensure you are up to date with colleagues.
Take part in this workshop to join us in:
- Elucidating which animal models may be favored by regulatory bodies to strategize approval pathways and effectively progress into clinical phases
- Clarifying which types of data comply with regulatory guidelines, and facilitating actionable goals to acquire such data
- Addressing how tighter regulations on ex vivo CAR-T therapies may impact the in vivo space
- Discussing risk benefit considerations for younger patient populations and developmental and reproductive risk considerations
- Navigating long-term clinical follow-up plans and requirements
