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Quality Requirements for Biotech Products from First-In-Human to Phase III


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Quality Requirements for Biotech Products from First-In-Human to Phase III training covers key topics:

  • Regulatory framework for Clinical trials of Biotech-IMPs
  • The quality challenges for Biotech-IMPs
  • GMP requirements for IMPs
  • Manufacturing of the Drug Substance and IMP
  • Requirements for process validation
  • IMPs comparators and placebos
  • Release specifications versus In-Process Controls, ICH guidelines
  • Analytical methods throughout clinical development, Batch data
  • The site master file (SMF)
  • Manufacturing process changes during clinical development

Contact

Lubomira Zaujecova
event.inquiries@fleming.events

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