Per Niklasson

AstraZeneca
Regulatory CMC Director
Per Niklasson has 30 years of experience in the pharmaceutical industry and has held different roles within regulatory affairs connected to CMC. He is CMC Regulatory Affairs Director at AstraZeneca. He has a wide range of experience in the strategic and tactical aspects of pharmaceutical drug development and global regulatory CMC knowledge, including strategic aspects of rolling out global applications for clinical trials, marketing applications, and postapproval submissions for major changes. Per has direct experience with health authorities meetings globally including FDA and CDE. He has extensive global line management experience. Per has a MSc in chemical engineering from Lund, Sweden, and a diploma in regulatory affairs from TOPRA. He has been an ISPE member since 2021.

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A New Regulatory Approach to Drive Sustainable Medicines
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A New Regulatory Approach to Drive Sustainable Medicines

To enable changes across the pharmaceutical industry, sustainability should be included alongside quality, efficacy, and safety when assessing medicines. This article reviews two case studies that cover sustainable pack types and extension of shelf life. With the drive to manage unmet medical need through acceleration of drug development programs, postapproval sustainability variations will...