Agenda
8:00 AM — 9:30 AM
A Regulatory Perspective of Biosimilars in Emerging Markets8:00 AM — 9:30 AM
Expediting Drug Development and Review for Serious Conditions10:15 AM — 11:45 AM
The Aging Population: Approaches to Ensure Safety and Efficacy1:45 PM — 3:15 PM
Electronic Submissions in PDUFA V1:45 PM — 3:15 PM
US and EU Regulatory Update of Clinical Trial Disclosure4:00 PM — 5:30 PM
Labeling and Patient Medical Information (PMI)10:15 AM — 11:45 AM
Advancing Alzheimer’s Innovation: A Call to Action1:45 PM — 3:15 PM
FDASIA Patient Provisions: One Year Later4:00 PM — 5:30 PM
Global Pediatric Development: Next StepsHave an account?