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Learning Level: Foundational
Learning Level: Foundational
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Learning Level: Intermediate
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Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Networking Event
Networking Event
Sponsor Presentation
Sponsor Presentation
Ticketed Event
Ticketed Event

Olga Braem, PhD

Head of CMC Regulatory for North America
Kyowa Kirin, United States

Olga Braem, PhD, is a professional with 20+ years of pharmaceutical industry experience in Global Regulatory Affairs and Pharmaceutical Development. During the past 8 years, led the development of CMC strategies and regulatory approaches for biological, small molecule, and combination product submissions such as INDs/IMPDs, BLAs/NDA/MAA/NDS that resulted in multiple drug approvals in the US, EU and globally. Authored CMC global pre- and post-approval submissions, knowledgeable in the US and global CMC regulatory requirements. Proven subject matter expert in the areas of biologic bioanalytical and formulation development that guides global teams on successful multi-regional CMC strategies.

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