Statistical Concepts for Comparability Assessment: The EMA Reflection Paper
The recently released reflection paper (draft) from the European Medicines Agency (EMA) aims to establish a framework and a common language to define the appropriate role of inferential statistical methods for comparative evaluation of drug product’s quality characteristics. This is a scientific challenge in the sense of answering the different comparison questions based on relevant data and using appropriate statistical methods, and understanding all the sources of variability involved. It’s also a challenge in bridging understanding of all problems at hand and limitations involved between regulatory statisticians, quality assessors, and their industrial counterparts. The common interest is that improved assessment of similarities at the quality level will benefit patients, as well as drug development efficiency.
The ISPE Process Validation Statistics Conference will provide a unique opportunity to have your voice heard on the EMA reflection paper. The keynote speaker will be Dr. Kit Roes from the University Medical Center Utrecht, who is a representative of the EMA Biostatistics Working Party and prepared the paper.
In his presentation, Dr. Roes will present the essence of the reflection paper, while explaining the underlying concepts, building on experience as a regulatory statistician, as well as from using statistical concepts to control and continuously improve quality of (complex) production processes. The discussion session will also be one avenue for you to provide input to ISPE’s official response to the reflection paper.
Don’t miss this opportunity to share your thoughts and hear from others in the industry!
View the complete education program to see what else you’ll experience at the conference.
Double the Learning and Increase Your Savings!
Get the most of your experience by also attending the 2017 ISPE Process Validation Conference, which takes place right before the Process Validation Statistics Conference. Save an additional 25% by registering for both conferences.