Barbara Bonamassa

Company: Italian Medicines Agency (AIFA)

Job title: Quality Assessor & European Medicines Agency (EMA) Expert for ATMPs

Seminars:

Panel Discussion: Building the Plane as They Fly It 9:45 am

• Early stage, late stage, and regulators perspectives on common analytical hurdles • Where is there room novel technologies and surrogate assays? • Q&A sessionRead more

day: Day Two

The European experience on testing of Advanced Therapy Medicinal Products 8:15 am

• Discussing general expectations on analytical methods • Highlighting the challenges/differences as compared to standard biological medicinal products • Sharing experience gained in the context of the European early access program PRIMERead more

day: Day Two