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Tuesday, June 26 • 1:15pm - 2:00pm
#249: Global Evolution in Regulatory Science and Medicine: Novel Modalities and Intersection with Rare Disease Development

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Component Type: Workshop
Level: Intermediate

We explore the rapid advancements in science and medicine leading to new complexities in the drug development ecosystem for rare diseases. Also, we examine and deliberate on the heterogeneous nature of regulatory frameworks globally for the treatment

Learning Objectives

Discuss the intersection of precision medicine and rare disease drug development, including potential challenges; Explain, in general terms, about the global regulatory policy issues facing rare disease drug development.


Nina S. Cauchon, PhD, RAC


Nina Cauchon

Regulatory Affairs - CMC, Amgen Inc.
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She was a lead for early phase & commercial programs, including both small molecules & biologics. She is chair of the AAPS CMC Community, and is active on the ISPE Expedited Regulatory Pathways workstream. Her... Read More →

Tuesday June 26, 2018 1:15pm - 2:00pm EDT
E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA