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Conrad Cairo Hotel

2024年11月25日 (月) 午後 6:00 - 2024年11月27日 (水) 午後 6:00

1191 Nile Corniche, Cairo, 11221, Egypt

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.

Parallel Session 7B: Advanced Therapies

Session Chair(s)

Kowid  Ho, PharmD

Kowid Ho, PharmD

Pharma Technical Regulatory Policy

F. Hoffmann-La Roche Ltd, Switzerland

Asmaa  Ahmed

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)

Kowid  Ho, PharmD

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

Anna  Litsiou, PhD, MBA, MSc

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

Speaker  Invited

SFDA's experience with CGTs approval

Speaker Invited

China

Asmaa  Ahmed

Panel Discussion with Q&A

Asmaa Ahmed

Egyptian Drug Authority (EDA), Egypt

Researcher and Head of Biotech lab

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