Agenda / Day 1

Writing a CMC Package Reviewers Can Follow

2:25 pm – 3:00 pm

Garden Studio

Regulatory

About this session

Structure, evidence and common gaps in CMC submissions for novel modalities.

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Parallel streams

Streams

Stream C – Regulatory Pathways

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Who's speaking

Speakers

Dr Julia Novak

Head of CMC

Talvera Therapeutics

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