Advanced CMC Masterclass - EU edition

PROGRAM UPDATE!

TRAINING PROGRAM FOR CMC LEADERS - EU EDITION 14th September 2026 - 09th April 2027

Overview

This advanced training course covers the key CMC aspects in the development of drug substances and medicinal products, including analytical development and the product life cycle management with regard to manufacturing processes and analytical procedures. It begins with an introduction to the regulatory documents - specifically the ICH guidelines - that outline the requirements for the proper development of drug substances and drug products and specify the technical information that have to be submitted to the regulatory authorities as part of marketing authorization applications (MAAs, NDAs, etc.).

Based on the quality-by design principles and utilizing quality risk assessment, the training explains the various stages of drug substance / drug product development - such as the selection of starting materials / excipients, the linking of critical process parameters (CPPs) to critical quality attributes (CQAs), and the establishment of the control strategy (including setting of specifications for starting materials / excipients and finished drug substances / drug products). In addition to the process development of active ingredients and medicinal products, the training course covers key aspects of analytical development for drug substances and drug products including the development and validation of analytical procedures. Furthermore, the course provides insight into the selection of primary packaging materials (container closure system) and stability testing to establish the storage conditions and shelf life for the drug substances and drug products.

In addition to these topics, the training course covers clinical phase-dependent approaches used in pharmaceutical and analytical development, as well as post-approval changes within the scope of product life cycle management - such as transfer of analytical procedures.
 

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