Marianne Braathen Holm

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Ferring Pharmaceuticals A/S, Copenhagen, Denmark
Global Regulatory Lead, CMC, in Global Regulatory Affairs
Marianne Braathen Holm is Global Regulatory Lead, CMC, in global regulatory affairs at Ferring Pharmaceuticals A/S, Copenhagen, Denmark. In 15 years in the industry, she has worked with areas of regulatory affairs CMC, both in development and life-cycle management. Her main interests are drug substance and drug product manufacturing processes and control strategies, with most experience with synthetic peptides and microbiome products. Marianne has a Cand.Pharm (Master of Pharmacy) from the University of Oslo, Norway.

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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...