Gregory Rullo

AstraZeneca
Executive Director, Regulatory Affairs-CMC
Greg Rullo is an executive director of CMC Regulatory innovation at AstraZeneca and has a wide range of experience in the strategic and tactical aspects of pharmaceutical drug development and global regulatory cmc knowledge. This regulatory knowledge/experience includes CMC specific knowledge of requirements of global cmc requirements with a detailed understanding of submission requirements in Brazil. He has direct experience with Health Authorities meetings throughout the world including: FDA, EU health authorities, ANVISA, Health Canada and Chinese authorities. He was AstraZeneca’s Global Program Director for the integration and implementation of AstraZeneca’s sole regulatory document management, regulatory publishing and submission tracking systems.

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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...