Module 1 2021

25/06/2021

TOPRA Module 1 – Strategic Planning in RA

The Relationship between Regulatory Affairs and Project Planning

Elke Litzlbauer, PhD, Takeda

The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

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My coordinates…

Mag. Dr. Elke Litzlbauer, MSc • graduated in Natural and Medical Sciences (Uni & Med. Uni Vienna) • MSc in Regulatory Affairs (Uni Wales, UK) • PMP certification planned • Pharmaceutical Industry, Regulatory Affairs since 2006, Biologicals (Baxter AG, Baxter Innovations GmbH, Baxalta Innovations GmbH, Shire, Takeda GmbH) • CMO Management/ External Manufacturing Plasma/ Plasma Innovations since 2015 • Currently on Assignment in Amsterdam

elke.litzlbauer@takeda.com

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The Organisation for Professionals in Regulatory Affairs

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