Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
On-Demand Presentation by Dr. Anne Ries (Boehringer Ingelheim)
Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods – Linearity Testing, Total Error Approach
On-Demand Presentation by Dr. Pierre Lebrun (Cencora – PharmaLex)
ICH Q2 Revision 2 and Method Development and Validation Objectives (Analytical Target Profile)
On-Demand Presentation by Dr. Joachim Ermer (Ermer Quality Consulting)
Insights on specification setting challenges and opportunities
On-Demand Presentation by Dr. Simona Cianetti (GSK)
Patient-Centric Commercial Specifications for Biotherapeutic Products, Strategies and Case studies
On-Demand Presentation by Dr Eric Rozet (GSK)
Basic regulatory science behind drug substance & drug product specifications of monoclonal antibodies
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On-Demand Presentation by Dr. Patanachai “Kong” Limpikirati (Chulalongkorn University)
Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile
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On-Demand Presentation by Prof. Sandra Furlanetto (University of Florence)
Critical Analytical Procedure Parameters and Risk Assessments
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On-Demand Presentation by Dr. Cyrille Chéry (UCB)
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