This workshop aims to identify current scientific and regulatory challenges of in vivo and in vitro gene editing (GE) medicines. Input from the workshop will assist the CAT in developing new guidance for these products.
The workshop has an open session and a closed session.
During the open session, academic experts provide general information on the different editors, the methods for off-target analysis, the state of clinical development and common challenges for clinical application of GE products. This is followed by a discussion session between CAT experts and GE developers.
During the closed session, selected developers from industry and academia are invited to present to CAT their experience with GE medicinal product developments.
To safeguard the confidential information that is shared, only participants for Regulatory Authorities in EU are allowed to attend the closed sessions.