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White Papers

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Emprove/Whitepaper-Chinese-Excipient-Regulation-Millipore-2019-1.jpg Cloris Tian, Senior Regulatory Manager, APAC, Shanghai, China, and Yuwei Heinzel, Head of Pharma Registration Germany, Merck KGaA, Darmstadt, Germany on: Chinese Excipient Regulation – a Globally Unique Challenge

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Emprove/Risk_Assessment_Whitepaper_MSIG_Sept_2019-1.jpg Frithjof Holtz, Advocacy & Surveillance, Life Science Regulatory Management, Merck KGaA, Darmstadt, Germany on: EU Excipient Risk Assessment Guidelines – Practical Implementation Experience

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Emprove/WP3014EN _MSIG-1.jpg Satish Kumar Mohanvelu, Marketing Manager, Emprove® Program, MilliporeSigma, Jessica Shea, Global Technical Support, on: The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Emprove/MS_WP3015EN-1.jpg Douglas Bowman, Program Manager, Emprove® Program, on: Identifying Appropriate-Quality Raw Materials in an Evolving Regulatory Environment

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Emprove/White-Paper-Risk Assessment-Single-use.jpg Janmeet Anant, Regulatory Advocate, on: Risk Assessment for Single-Use Pharmaceutical Manufacturing Systems

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Emprove/White-Paper-Biosimilars.jpg Janmeet Anant, Regulatory Advocate, on: Biosimilars: Regulatory Trends and Manufacturing Considerations

Dr. Ulrich Reichert, Head of Pharma & Food Materials, Regulatory Management, on: Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients, published in American Pharmaceutical Review

Articles and Interviews

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Emprove/Assessment-for-Excipients.jpg PDA Letter
Frithjof Holtz, Head of Advocacy and Surveillance for Regulatory Management, on: Establishing a Formalized Risk Assessment for Excipients

European Pharmaceutical Manufacturing
Heike Michaelis, Director of the Emprove® program, and Frithjof Holtz, Head of Advocacy and Surveillance for Regulatory Management, on: Risky business: Establishing quality risk assessments