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Parallel Session 7A: The Evolution of Digital Submissions
Session Chair(s)
Dalia Fouad
Middle East Region Head - Global Regulatory Affairs
Sanofi Aventis, United Arab Emirates
In this session, we will navigate through the lesson' learned from the implementation of eCTD in the Middle East region, while exploring the future of regulatory submission through digital transformation. From the new Continental IMS in Africa to the transition to cloud technology, this session promises to be an exciting moment to look into the future and how to support all stakeholders in their digital transformation efforts.
Speaker(s)
A Vision for Digitalisation in the MENA region
Ralph Lee
Pfizer , United Kingdom
SM Lead: Türkiye & CauCAR Clusters
Regional Deep-Dive: Where are we now?
Ralph Lee
Pfizer , United Kingdom
SM Lead: Türkiye & CauCAR Clusters
Regional Deep-Dive: Where are we now?
Assmaa Yousry
Egyptian Drug Authority (EDA), Egypt
PPMA Quality Assurance Unit Manager & Senior Pharmacist - PPMA
Regional Deep-Dive: Where are we now?
Sana Dabbech
Ministry of Public Health, Tunisia
Pharmacist - LNCM/ ANMPS
New Continental IMS Working Group Africa – How is the system being set? How are learnings from other regions being utilised?
Chimwemwe Chamdimba
African Union Development Agency-NEPAD, South Africa
African Medicines Regulation Harmonization Programme Head
Update on ICH M4Q/R2
Sara Magdy
Egyptian Drug Authority (EDA), Egypt
Head of Technical Support administration, General Admin of Biological Products
Regulatory Innovation: Strengthening collaboration through cloud-based platforms to accelerate medicines to patients
Fabio Bisordi, MSc
F. Hoffmann-La Roche Ltd, Switzerland
Global Head International Regulatory Policy
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