Sabine Ruehle, Regulatory Affairs Senior Associate at Boyds, presented at the BIA UK Bioscience Forum 2019 in October at County Hall in Westminster.
Sabine’s talk on “Bench to bedside: preclinical considerations for advanced therapies” explored what is needed from the regulatory and safety perspective for the preclinical work to support the administration of ATMPs to humans and how this differs from the requirements of an NCE. The talk considered some of the manufacturing aspects particularly relating to the standards of manufacturing required to generate ATMP material to use in the preclinical work.
Click on the link to view the slides: BIA – Nonclinical Aspects ATMPS and for more information, contact a member of the team.
