Main Workshop DAY 2B - Wednesday April 14, 2027: 12:30pm - 5:45pm - Discussion Topic List
"Regulators' Advice on Immunogenicity/Technologies of Biotherapeutic, & Gene, Cell & Vaccine Therapies"
Session 1: Immunogenicity of Biotherapeutics
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA, Austria AGES/ EU EMA, Health Canada
Ask the Regulators any questions you have on Immunogenicity of Biotherapeutics, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes
Session 2: Gene Therapy, Cell Therapy, and Vaccines
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA, EU EMA, UK MHRA, Health Canada
Ask the Regulators any questions you have on Gene Therapy, Cell Therapy, and Vaccines, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes
