Refining Preclinical Regulations: Clarifying Requirements for Safety, Efficacy, and Pharmacological Evidence to Establish the Regulatory Gold Standard & Minimize Uncertainty in Clinical Translation
Time: 1:00 pm - 4:00 pm
day: Pre-Conference Workshop
Details:
As the in vivo cell engineering and gene editing space rapidly develops, leaving uncertainties in regulatory requirements, this workshop delves into considerations for effective model selection and strategies for producing comprehensive safety and efficacy evidence to effectively prepare for treatment evaluation and approval from regulatory boards.