16th October 2014
How similar must biosimilars be?
Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA
The analytical characterisation undertaken to support quality assessment of a biosimilar is identical to that required for any novel biopharmaceutical product but with a very important additional requirement – the need for a very comprehensive comparison with a licensed reference product.
If you are working with biopharmaceuticals, do you understand why this is so? What are the key factors that can differ between a biosimilar and an originator product? Why do the characterisation methods often differ? What effects do these differences have on the safety and efficacy of the biosimilar product?
Are you aware of the FDA draft guidance on "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product" and its relationship to EMA guidance?
This symposium will identify and review the process of bringing these types of product to market and show how comparability needs to be demonstrated to gain regulatory approval. If your work involves the quality of biopharmaceuticals - and particularly if you are a QP – this is an event you must not miss.

5th February 2015
Quality Risk Management: a pragmatic approach
GlaxoSmithKline, Ware
An effective quality risk management (QRM) process provides a key mechanism for the proactive identification and control of potential issues that may arise during product development and subsequent commercialisation (ICH Q9).
Scientific approaches are used to estimate the likelihood of any given risk.
This symposium will look at the assessment of risk from an academic, regulatory and industrial perspective and will cover method development, specification setting, chemical purging and genotoxin risk assessment (GRA) using in silico methodologies.