Equip and De-Risk Your Microbiome Drug Development for the European Market – Regulatory Science and a ‘Development-by- Design’ Approach

Time: 4:55 pm
day: Day Two


  • Overview of the current European regulatory framework surrounding microbiome drug development
  • Microbiome drug products are Biologics – applying the Development-by-Design mindset and the added value of tools such as the TPP; QTPP and Risk Analysis
  • Potential future evolution of the European regulatory framework; ongoing revision of the Blood, Tissues & Cells legislation