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Keynote Regulatory Roundtable - perspectives on key areas of importance to the cell & gene therapy industry

20 Jan 2027

09:00 - 09:30

Theatre 1

Plenary

• IND & BLA feedback; CMC guidance; global regulatory divergence; acceptability of ex-US/EU IIT-derived clinical data

• How and where will the world's regulatory bodies utilise AI moving forward?

Speakers

Dr Steven Oh, Director, Office of Cellular Therapy and Human Tissue, Office of Therapeutic Products, CBER - US Food & Drug Administration

Dr Yoshiaki Maruyama, Director, Office of Cellular and Tissue-based Products - Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Topic

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Persona

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