Middle East and North Africa Conference (MENA)

This two-day conference is designed for the industry's regulatory professionals to explore the evolving pharmaceutical landscape in the MENA region and address its unique challenges, with all regional regulators present.

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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

Head of Biotech lab-EDA

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

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Middle East and North Africa Conference (MENA)

Parallel Session 7B: Advanced Therapies

Session Chair(s)

Kowid Ho, PharmD

Asmaa Ahmed

Speaker(s)

Overview of international activities on Cell and Gene Therapy, focusing on WHO guideline and ICH CGT discussion group

Convergence of CGT regulations – Trends in CGT Development, Best Practices in Regulating CGT and Regulatory Pathways for CGT in the US, EU & Japan

SFDA's experience with CGTs approval

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