Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

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TitleWorkshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
Date03/05/2018 - 04/05/2018
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Agenda - Workshop on draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (English only) 2018-07-05  
List of participants - Workshop on draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (English only) 2018-07-05  
Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (English only) 2017-03-31  
Presentation - One size doesn’t fit all - Why it should be different guidances (B. Boulanger, EFSPI) (English only) 2018-07-05  
Presentation - Medicines for Europe’s view on the application of statistical methodology for comparability (M. Schiestl, Sandoz Biopharmaceuticals) (English only) 2018-07-05  
Presentation - Statistical tests, Bayesian analysis, or heuristic rules for demonstration of analytical biosimilarity? (R. Burdick, Elion Labs) (English only) 2018-07-05  
Presentation - Current Issues in Biosimilar Regulatory Submission in US (S-C. Chow, FDA) (English only) 2018-07-05  
Presentation - Considerations on biological APIs extracted from material of human and animal origin (R. van Herpen, APIC) (English only) 2018-07-05  
Presentation - Manufacturing Change for a Biological Product (V. LeBras, Merck) (English only) 2018-07-05  
Presentation - Comparability study to support commercial process change via stability study (B. Teodorescu, EBE, UCB) (English only) 2018-07-05  
Presentation - Workshop on the Use of Statistical Methodologies in the Comparability Assessment of Quality Attributes (H. Park, Samsung Bioepis) (English only) 2018-07-05  
Presentation - Practical considerations in the statistical evaluation of biosimilarity - a laboratory perspective (H. Kuehne, Coherus Biosciencies) (English only) 2018-07-05  
Presentation - EMA Workshop Case Study on Analytical Similarity (J.G. Ramirez, Amgen Inc.) (English only) 2018-07-05  
Presentation - Case Study on Statistical Comparison of Stability Data - Importance of Data Quality (F. Innerbichler, Novartis) (English only) 2018-07-05  
Presentation - Operating characteristics of frequently used similarity rules (F. Klinglmueller, Austrian Medicines and Medical Devices Agency) (English only) 2018-07-05  
Presentation - Performance characteristics of quality range methods and equivalence testing in the comparative assessment of quality attributes (T. Stangler, Novartis) (English only) 2018-07-05  
Presentation - Analytical Similarity Assessment (S-C. Chow, FDA) (English only) 2018-07-05  
Presentation - The Importance of Properly Designed Experiments for Comparative Studies (R. Shaw, AstraZeneca) (English only) 2018-07-05  
Presentation - Statistical methodology for biosimilars, comparison of process changes and comparison of dissolution profiles (M. Denham, EFSPI) (English only) 2018-07-05  
Presentation - The value of Bayesian statistics for assessing comparability (T. Mutsvari, EFSPI) (English only) 2018-07-05  
Presentation - Establishing, Assessing, and Comparing Quality Attributes from a Small Sample of Development Batches through Full-scale Production (K. Vukovinsky, Pfizer) (English only) 2018-07-05  

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