Margit HolzerScientific Director at Ulysse ConsultSpeaker
Profile
Margit Holzer is a passionate biochemical engineer with internationally recognized expertise in development, industrialization and implementation of biotechnological production processes, in the field of pharma and food applications. She holds a master and a PhD in biotechnology from the University of Natural Resources and Applied Life Sciences in Vienna (Austria). Margit has worked all over Europe for Boehringer-Ingelheim and Novasep, she headed various positions in R&D, production, quality, technology and business including several worldwide executive ones. Since end of 2012 she serves the industry as an independent consultant at Ulysse-Consult. Amongst other achievements she has supervised product and process development of more than 50+ different products (from small to large molecules including mAb & other recombinant proteins, vaccines, plasmids, and advanced therapies), several of them reached market authorization.
Agenda Sessions
Setting the Scene : CMC Studies in the life cycle
, 9:00amView SessionRequirements from Pre-Clinical to Phase 2 CT
, 11:00amView SessionRequirements from Pre-Clinical to Phase 2 CT
, 1:00pmView SessionRequirements from Pre-Clinical to Phase 2 CT
, 2:00pmView SessionRequirements from Pre-Clinical to Phase 2 CT
, 3:00pmView SessionFinal Q&A Session & Closing Remarks
, 4:00pmView Session