2018 PharmSci 360
SEPARATE FEE AND REGISTRATION REQUIRED.
The ADA Validation Testing and Reporting Global Harmonization (ADAH) AAPS sub-group was formed in 2017 following the intense debate at the National Biotechnology Conference that confirmed the need for standardized expectations and templates for data summary in immunogenicity validation reports. The ADAH sub-team has 32 members, representing 30 organizations (including 5 from Europe and 6 from FDA), selected to identify the best immunogenicity reporting practices from across the industry.
This short course will provide a detailed update of current expectations for immunogenicity validations and a preview of the ADAH recommendations. Presentations and discussions will prepare workshop attendees for future regulatory submissions.