Emprove® Program Tools:
Risk Mitigation Tool: Support for Biomanufacturing Processes
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Maren Apostel, Emprove® Program Manager, Merck KGaA, Darmstadt, Germany on: A practical approach for determining extractables in chromatography resins in the light of the upcoming USP chapter <665> |
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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 |
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Frithjof Holtz, Advocacy & Surveillance, Life Science Regulatory Management, Merck KGaA, Darmstadt, Germany on: EU Excipient Risk Assessment Guidelines – Practical Implementation Experience |
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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 |
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Douglas Bowman, Program Manager, Emprove® Program, on: Identifying Appropriate-Quality Raw Materials in an Evolving Regulatory Environment |
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Janmeet Anant, Regulatory Advocate, on: Risk Assessment for Single-Use Pharmaceutical Manufacturing Systems |
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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 | |
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