Quality Requirements for Biotech Products from First-In-Human to Phase III

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PROGRAM

Day 1

26 April

European regulatory landscape for Clinical trial procedures
European regulatory framework and requirements
Biotech-IMPs : The challenges
The A section and basic requirements for manufacture

Day 2

27 April

Manufacture of the Drug Substance
Manufacture of IMPs, comparators and placebos
Characterization of Drug Substance and IMPs
Control of the Drug Substance and IMPs

Day 3

28 April

Stability requirements for Drug Substance and IMPs
Manufacturing process changes during clinical development
CTA: Quality meets GMP
Typical regulatory Quality issues and general pitfalls during clinical development