Event

Workshop on Cell and Gene Therapies

  • 23 Oct 2018
  • 14:00PM
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  • Karstens Conference Centre, Melbourne, VIC, Australia

ERA Consulting



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About the Event

This workshop will focus on how cell and gene therapies (advanced therapy medicinal products, “ATMPs”) should be prepared for clinical development to meet the requirements of regulatory authorities, particularly in the EU and US. We will provide attendees with a regulatory scientific approach for successful translation of ATMPs into the clinic. The content will include an overview of the applicable regulatory pathways and essential elements to address prior to application to perform clinical trials. This will include practical advice on “dos and don’ts” for product design and manufacturing platform selection.

Topics:

  • Factors in the design of cell and gene therapies that impact acceptability to regulatory authorities in the EU, US and Australia
  • Considerations in selection of the manufacturing platform
  • Essential product testing before entry into clinical trials
  • Pre-clinical studies that are relevant to the safety of cell and gene therapies
  • The value of regulatory strategies in the early development of cell and gene therapies