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Session 6B: Biologics: Statistical Methodology for Comparative Assessment of Quality Attributes in Drug Development
Session Chair(s)
Martin Schiestl, PhD
Global Head Regulatory Affairs Policy
Sandoz GmbH, Austria
EMA issued a draft Reflection Paper in March 2017 and discussed the draft in a stakeholder workshop in May 2018. The scope of it includes manufacturing process changes for biologicals, biosimilar evaluation and generics. FDA on the other hand published a relatively prescriptive biosimilar specific draft guidance on “Statistical approaches to evaluate analytical similarity”. The session will highlight the main aspects of this guideline development and will also reflect the outcome of the EMA May workshop.
Speaker(s)
Meaningful Statistical Approaches in the Comparison of Quality Attributes
Martin Schiestl, PhD
Sandoz GmbH, Austria
Global Head Regulatory Affairs Policy
EMA Workshop on the Draft Reflection Paper: Outcome, Learnings and Next Steps
Thomas Lang, MSc
Austrian Agency for Health and Food Safety (AGES), Austria
Senior Statistical Assessor
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