BioInsights - Global regulatory update - spotlight

CELL & GENE THERAPY INSIGHTS

July 2022

Global regulatory update

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Interview

Inside the UK’s brave new world of ATMP regulatory innovation

Inside the UK’s brave new world of ATMP regulatory innovation

Jacqueline Barry

Evolving ATMP regulations in the EU & UK, & the role of the Qualified Person

Evolving ATMP regulations in the EU & UK, & the role of the Qualified Person

David Caulfield

Trends in academic ATMP development & manufacture in Europe

Trends in academic ATMP development & manufacture in Europe

Pauline Meij

Regulatory learnings for the next wave of cellular immuno-oncology agents

Regulatory learnings for the next wave of cellular immuno-oncology agents

Robert Pietrusko

Cell & gene therapy R&D & regulatory evolution in the United Arab Emirates

Cell & gene therapy R&D & regulatory evolution in the United Arab Emirates

Asawari Bapat

Viewpoint

Recent gene-editing guidance from FDA – clarifies some gene-editing development questions with room for additional recommendations

Recent gene-editing guidance from FDA – clarifies some gene-editing development questions with room for additional recommendations

Kathleen Candando, Karl Whitney

Regulatory perspective

A need for a novel regulatory framework for individualized neoantigen-specific therapies

A need for a novel regulatory framework for individualized neoantigen-specific therapies

Amy Hardwick, Kathleen Francissen

Webinars

International differences in cellular starting material quality and regulatory requirements

International differences in cellular starting material quality and regulatory requirements

B Kuker, P Machalik, S Ahmed et al.