Meeting at Monash Institute of Pharmaceutical Science

Level 5 meeting room in building 4 (399 Royal Parade). Visitors can sign in at security in the lobby of that building (enter into 399 Royal Parade past the café on your right and security is in front and on your left). Then go to level 5 in the lifts just past security and come out of the lifts through the glass swinging door and turn right. The meeting room is at the end of that passageway and fronts onto Royal Parade.

Main presentation: FDA Modernisation act 2.0: bringing non-animal technologies to the regulatory table - presentation by Alistair Stewart, University of Melbourne

The surge in interest in human specific therapeutics, the increasing recognition of the poor predictive value of certain animal studies and increasing confidence in the utility of microphysiological systems, including organoids and organ on a chip, are drivers of important regulatory changes that impact on drug discovery and development.  This presentation will consider whether the precinct should have a concerted plan to ensure sovereign capability and competitiveness in this rapidly changing drug development environment.