会议日程
8:15 AM — 8:30 AM
8:30 AM — 9:00 AM
Session 1: Introduction to Combination Products9:00 AM — 9:30 AM
Session 2: Combination Products by Type9:30 AM — 10:30 AM
Session 3: Determining Regulatory Route for Approval10:30 AM — 11:00 AM
11:00 AM — 12:00 PM
Session 4: Regulatory Pathway by Center12:00 PM — 1:00 PM
1:00 PM — 2:15 PM
Session 5: Product Development2:15 PM — 3:00 PM
Session 6: Patient Focus3:00 PM — 3:30 PM
3:30 PM — 4:30 PM
Session 7: Working with FDA Review Centers4:30 PM — 5:00 PM
Wrap up and Questions Day One8:15 AM — 8:30 AM
8:30 AM — 9:15 AM
Session 8: Safety Reporting9:15 AM — 10:30 AM
Session 9: Safety Reporting Workshop10:30 AM — 11:00 AM
11:00 AM — 12:00 PM
Session 10: Post-Approval Changes12:00 PM — 1:00 PM
1:00 PM — 2:15 PM
Session 11: Post-Approval Changes Workshop2:15 PM — 3:00 PM
Session 12: Good Manufacturing Practices for Combination Products3:00 PM — 3:30 PM
3:30 PM — 4:15 PM
Session 13: GMP Workshop4:15 PM — 4:30 PM
Wrap-up/Questions and Answers