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Cell & Gene Therapy International Europe

Savings Deadline Expires In:

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2-4 December 2024
Convention Centre DublinDublin, Ireland

Margit Holzer, Ph.D.
Senior Scientific Director at Ulysse Consult S.a.r.L
Speaker

Profile

Dr 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

  • Relevant Regulatory Background in the Field of CGT + QbD/Quality by Design (QbD) Concept and Approaches

    09:00
  • Risk Management Methodologies and Practical Considerations

    11:00
  • Stages in Process Development + Process Characterization

    13:00
  • Process Development Gene Therapy & Cell Therapy – Typical Studies and Specific Requirements

    15:00