Quality Requirements for Biotech Products from First-In-Human to Phase III 2018

Quality Requirements for Biotech Products from First-In-Human to Phase III 2018 is a workshop dedicated to quality Requirements for Biotech Products from First-In-Human to Phase III.

Topics

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