Richard Klein

Richard Klein

Company: GE2P2 Global Foundation

Job title: Director, Expanded Access Programs and Policy


Unpacking Expanded Access Regulations in the United States 11:00 am

Exploring the different kinds of expanded access for the treatment use of investigational agents Discussing what kinds of access are possible under FDA regulations Assessing who is eligible for expanded access and who makes the decisions  Read more

day: Day One

Panel Discussion – Navigating Global Data Generation Regulations 9:00 am

• Incorporating data collection into expanded access programs • Harnessing data for regulatory filings • Managing global compliance rules when collecting data in an expanded access programRead more

day: Day Two

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