KeAndra Robinson

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Biogen
Regulatory Affairs Senior Manager
KeAndra Robinson is a Regulatory Affairs Senior Manager at Biogen and a lead regulatory strategist for late-phase clinical programs and product registration globally. KeAndra has extensive chemistry, manufacturing, and controls experience in the pharmaceutical industry and a diverse background in small molecules and antisense oligonucleotides therapies. KeAndra is the Cochair of the IQ Consortium Control Strategy Global Harmonization Working Group. She has a MS in both chemistry and regulatory affairs for pharmaceutical drugs, biologics, and medical devices.

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Figure 3: Industry develops a single global control strategy.
Features
Toward a Single Global Control Strategy: Industry Study

During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across geographic regions. This article shares data that highlight instances where well-established ICH...