Pre-Clinical Safety Analyses. Facilitators: Carla F. García PhD, Julia Klermund PhD and Manuel Rhiel PhD (Uni. Medical Center Freiburg)
This workshop will focus on the pre-clinical analyses that are essential to guarantee the safety of a gene-editing approach before it can be brought to the clinic. We will discuss the kind of safety data needed in order to obtain approval for a clinical trial, and the best methodologies for obtaining it. The main topics will be: - Regulatory guidelines for gene-editing safety. - Types of pre-clinical safety data necessary for approval. - Producing quality pre-clinical safety data to ensure approval. - The future of gene-editing regulations and how they will affect pre-clinical studies.