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CH: Addressing Key Challenges in Global Biosimilar Development and Regulation
Wednesday June 18, 2025 12:20pm - 12:50pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Explore National Regulatory Authorities’ expectations for quality data packages for biosimilars in the context of rapidly evolving regulatory science, including advanced analytical tools and the opportunity to reduce clinical data requirements.

Learning Objectives

Examine challenges identified by National Regulatory Authorities regarding review of quality data packages for biological products. Identify trends in regulatory expectations for analytical vs. clinical data and use of advanced analytical tools in biosimilar development. Understand opportunities and challenges in the use of public standards to meet regulatory expectations for biosimilars.

Chair

Allison Radwick, PhD, RPh

Speakers
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Wednesday June 18, 2025 12:20pm - 12:50pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Workshop |   15: Content-Hubs, Workshop

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