アジェンダ
7:15 AM — 8:15 AM
8:15 AM — 8:25 AM
Welcome and Opening Remarks8:45 AM — 9:45 AM
Session 1: Determining Biosimilarity: By Use of Totality of the Evidence9:45 AM — 10:15 AM
10:15 AM — 11:45 AM
Session 2: Critical Quality Attributes (CQA)11:45 AM — 1:00 PM
3:00 PM — 3:30 PM
4:30 PM — 5:30 PM
Session 5: Education5:30 PM — 6:30 PM
7:15 AM — 8:15 AM
8:15 AM — 8:30 AM
Welcome to Day Two8:30 AM — 10:15 AM
Session 6: Global Harmonization and Regulator Update10:15 AM — 10:45 AM
10:45 AM — 11:45 AM
Session 7: Ask the Regulators11:45 AM — 1:00 PM
Luncheon and Round Table Discussions1:00 PM — 2:30 PM
Session 8: Patient Access2:30 PM — 2:45 PM
2:45 PM — 4:45 PM
Session 9: Transitions and Interchangeability4:45 PM — 5:00 PM
Closing Session: Summary of Take-a-Ways and Calls to Action