Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
The European Medicines Agency has published a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA/CHMP/138502/2017), for a 1-year public consultation until 31 March 2018. In order to facilitate multidisciplinary interaction between regulators and stakeholders on statistical methodology applied to the quality of medicines, a 1.5-day workshop is held. The main focus of the workshop is the discussion of comments received during the public consultation. Stakeholders are therefore encouraged to provide comments well in advance (ideally by the end of November 2017).Stakeholders can express their interest to participate in this workshop by writing to RP-stats-QA@ema.europa.eu. Due to limited spaces, priority will be given to those who provided relevant comments. The output of the workshop will have a direct impact on the finalisation of the reflection paper.
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Meeting Report - Workshop on the draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA/CHMP/138502/2017) (PDF/203.81 KB)
First published: 03/10/2018
EMA/CHMP/579441/2018 -
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Agenda - Workshop on draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (PDF/330.68 KB)
Adopted
First published: 05/07/2018
Last updated: 05/07/2018
EMA/44715/2018 -
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List of participants - Workshop on draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (PDF/225.96 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (PDF/272.25 KB)
Draft: consultation closed
First published: 31/03/2017
Last updated: 31/03/2017
Consultation dates: 01/04/2017 to 31/03/2018
EMA/CHMP/138502/2017 -
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Presentation - One size doesn’t fit all - Why it should be different guidances (B. Boulanger, EFSPI) (PDF/419.57 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Medicines for Europe’s view on the application of statistical methodology for comparability (M. Schiestl, Sandoz Biopharmaceuticals) (PDF/647.91 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Statistical tests, Bayesian analysis, or heuristic rules for demonstration of analytical biosimilarity? (R. Burdick, Elion Labs) (PDF/360.93 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Current Issues in Biosimilar Regulatory Submission in US (S-C. Chow, FDA) (PDF/706.19 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Considerations on biological APIs extracted from material of human and animal origin (R. van Herpen, APIC) (PDF/485.39 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Manufacturing Change for a Biological Product (V. LeBras, Merck) (PDF/612.09 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Comparability study to support commercial process change via stability study (B. Teodorescu, EBE, UCB) (PDF/472.24 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Workshop on the Use of Statistical Methodologies in the Comparability Assessment of Quality Attributes (H. Park, Samsung Bioepis) (PDF/1.05 MB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Practical considerations in the statistical evaluation of biosimilarity - a laboratory perspective (H. Kuehne, Coherus Biosciencies) (PDF/1.18 MB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - EMA Workshop Case Study on Analytical Similarity (J.G. Ramirez, Amgen Inc.) (PDF/758.85 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Case Study on Statistical Comparison of Stability Data - Importance of Data Quality (F. Innerbichler, Novartis) (PDF/896.08 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Operating characteristics of frequently used similarity rules (F. Klinglmueller, Austrian Medicines and Medical Devices Agency) (PDF/1.11 MB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Performance characteristics of quality range methods and equivalence testing in the comparative assessment of quality attributes (T. Stangler, Novartis) (PDF/719.28 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Analytical Similarity Assessment (S-C. Chow, FDA) (PDF/1.14 MB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - The Importance of Properly Designed Experiments for Comparative Studies (R. Shaw, AstraZeneca) (PDF/719.07 KB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Statistical methodology for biosimilars, comparison of process changes and comparison of dissolution profiles (M. Denham, EFSPI) (PDF/1.32 MB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - The value of Bayesian statistics for assessing comparability (T. Mutsvari, EFSPI) (PDF/1.03 MB)
First published: 05/07/2018
Last updated: 05/07/2018 -
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Presentation - Establishing, Assessing, and Comparing Quality Attributes from a Small Sample of Development Batches through Full-scale Production (K. Vukovinsky, Pfizer) (PDF/820.67 KB)
First published: 05/07/2018
Last updated: 05/07/2018