Agenda
8:30 AM — 10:00 AM
Global Pediatric Development: We Are Making Progress11:00 AM — 12:30 PM
Fact or Fiction: Patient Engagement in the Drug Development Process11:00 AM — 12:30 PM
Pediatric Drug Development: Lessons Learned During FDASIA Implementation8:00 AM — 9:30 AM
Regulated Product Submissions and eCTD 4: The Path to Progress1:30 PM — 3:00 PM
Breakthrough Therapy Designation: One Year After3:30 PM — 5:00 PM
Prequalification of Medicines for Neglected Tropical Diseases3:30 PM — 4:30 PM
Utilizing 505(b)(2) to Accelerate Drug Development Plans8:00 AM — 9:30 AM
Regulatory Strategic Plan: Don’t Start Development Without One10:30 AM — 12:00 PM
From the Protocol to the Patient: Clinical Trial Data Disclosure10:30 AM — 12:00 PM
Implementation of GDUFA: Progress and Expectations3:30 PM — 5:00 PM
Health Authority Meeting Preparation: There Are No Do-Overs3:30 PM — 5:00 PM
The Realities of Late Life Cycle Management for Very Old Legacy Brands9:00 AM — 10:30 AM
Hot Topics in Medical Devices Labeling: US and Global10:45 AM — 12:15 PM
Trends in Biosimilars Regulation Within Developed and Emerging MarketsHave an account?