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Parallel Session 7B: Advanced Therapies
Session Chair(s)
Kowid Ho, PharmD
Pharma Technical Regulatory Policy
F. Hoffmann-La Roche Ltd, Switzerland
Asmaa Ahmed
Researcher and Head of Biotech lab
Egyptian Drug Authority (EDA), Egypt
This session explores the trend of Cell & Gene Therapies (CGT) development and the harmonisation work of CGT regulatory frameworks at a global level, namely at WHO and ICH. We will discuss the opportunity of leveraging ongoing harmonisation work and innovative pathways to facilitate the CGT approval in the MENA region and what is in the horizon for ATMPs.
Speaker(s)
Overview of international activities on Cell and Gene Therapy, focusing on WHO guideline and ICH CGT discussion group
Kowid Ho, PharmD
F. Hoffmann-La Roche Ltd, Switzerland
Pharma Technical Regulatory Policy
Convergence of CGT regulations – Trends in CGT Development, Best Practices in Regulating CGT and Regulatory Pathways for CGT in the US, EU & Japan
Anna Litsiou, PhD, MBA, MSc
AstraZeneca, United Kingdom
International Regulatory Affairs Policy And Intelligence
SFDA's experience with CGTs approval
Speaker Invited
China
Panel Discussion with Q&A
Asmaa Ahmed
Egyptian Drug Authority (EDA), Egypt
Researcher and Head of Biotech lab