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Advanced Therapy Medicinal Products in Israel: Evolving Regulation
Speaker Presentation Axelrod Ofra Ministry of Health 2018
Quality of Raw Materials and Manufacturing of Advanced Therapies
Speaker Presentation Atouf Fouad USP 2018
Control Strategy for Extractables and Leachables
Roundtable 10 Notes: AT Europe 2018
Software Considerations for Method Development and Data Evaluation
Roundtable 9 Notes: AT Europe 2018
Automation
Roundtable 8 Notes: AT Europe 2018
Implementation of USP<129>
Roundtable 7 Notes: AT Europe 2018
Phase Dependent Requirements for Method Validation Across the Globe
Roundtable 6 Notes: AT Europe 2018
Analysis of Polysorbate and Its Degradation Products
Roundtable 5 Notes: AT Europe 2018
How to Translate Physicochemical Properties into Claims of Safety and Efficacy
Roundtable 4 Notes: AT Europe 2018
Setting Specifications with Limited Batches and Analytics to Understand Process and Assay Variability
Roundtable 3 Notes: AT Europe 2018
Charge Variants Analysis (cIEF/icIEF, IEC, CZE)
Roundtable 2 Notes: AT Europe 2018
Mass Spec in QC
Roundtable 1 Notes: AT Europe 2018
What is the State of the Art Regarding Methods for Analysis of Glycans and Glycoproteins?
Roundtable 9 Notes: AT Europe 2019
Process Analytical Technologies
Roundtable 7 Notes: AT Europe 2019
Physio-chemical Methods to Replace Bioassays for Potency and Biological Activity Testing - Examples and Experience
Roundtable 8 Notes: AT Europe 2019
New CE-based Methods in the QC Lab - What Are the Challenges and Learnings?
Roundtable 6 Notes: AT Europe 2019
MS-based Methods in the QC Lab - What is the State of the Art?
Roundtable 5 Notes: AT Europe 2019
Hot Topic – Unmet Needs on Analytical Characterization
Roundtable 10 Notes: AT Europe 2019
HCP Testing Strategies
Roundtable 4 Notes: AT Europe 2019
Development of Chromatographic Methods; The New and the Old
Roundtable 3 Notes: AT Europe 2019