Sharing Regulatory Experiences to Produce IND-Enabling Analytics
Time: 1:30 pm
day: Workshop E
Details:
An exclusive session sharing regulatory experiences whilst preparing for Phase I clinical trial. Benchmarking the key agency expectations to fully inform high quality analytical development.
Key discussion points:
- Understanding the requirements for defining toxicology and the importance of appropriate animal models for assay development
- Exploring agency expectations for product qualification of identity and purity to produce a phase appropriate analytical suite
- Comparing stability within cryopreserved and fresh products to set your analytical development up for regulatory success
