Agenda
10:15 AM — 11:45 AM
Strategies for the Development and Registration of Antibody Drug Conjugates4:00 PM — 5:30 PM
Lessons Learned from the EMA-FDA Quality by Design (QbD) Pilot8:00 AM — 9:30 AM
Current Developments in the Automated NDA Field Alert Reporting Project8:00 AM — 9:30 AM
How to Prepare for Meetings, Both Internal and with the FDA10:15 AM — 11:45 AM
Drug Shortages: Causes, Current State and Path Forward9:00 AM — 10:30 AM
Postapproval Change Management: Challenges and OpportunitiesHave an account?