The Regulatory CMC (Chemistry, Manufacturing and Controls) and Product Quality Track provides a comprehensive overview of risk-based approaches throughout the product lifecycle.

The scope of the track spans scientific understanding gained through product and process development to lifecycle expectations for Global Regulatory CMC submissions, CGMP, and Quality Systems. Sessions address the increasing regulatory complexity in development and manufacturing for worldwide markets, global harmonisation, early patient access, pandemic medicines, new technologies, emerging regulations and the increasing scrutiny of manufacturing operations and data.

Who is This Track Designed For?

Professionals involved in CMC regulatory affairs and policy, manufacturing, quality assurance, quality control, drug development and/or manufacturing for small molecule drugs, biologics, vaccines and all modalities (ATMPs, oligonucleotides, etc).

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