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.
Quality Requirements for Biotech Products from First-In-Human to Phase III 2018 covers topics such as:
- 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)
