Ylva Hedberg

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AstraZeneca
CMC Regulatory Affairs Director
Ylva Hedberg has over 20 years of experience in the pharmaceutical industry and has held different roles in process technology, quality, and regulatory. For the past 13 years, Ylva has specialized in regulatory CMC requirements focusing on marketing applications and postapproval submissions. She is CMC Regulatory Affairs Director at AstraZeneca. Ylva has a wide range of experience in the strategic aspects of rolling out marketing applications globally and has played an instrumental role in setting the CMC content of marketing applications. She has a MSc in chemical engineering from the Royal Institute of Technology, Stockholm, Sweden.

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Figure 3: Industry develops a single global control strategy.
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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...