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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)
Ralph Lee
SM Lead: Türkiye & CauCAR Clusters, Pfizer , United Kingdom
A Vision for Digitalisation in the MENA region
Ralph Lee
SM Lead: Türkiye & CauCAR Clusters, Pfizer , United Kingdom
Regional Deep-Dive: Where are we now?
Assmaa Yousry
PPMA Quality Assurance Unit Manager & Senior Pharmacist - PPMA, Egyptian Drug Authority (EDA), Egypt
Regional Deep-Dive: Where are we now?
Sana Dabbech
Pharmacist - LNCM/ ANMPS, Ministry of Public Health, Tunisia
Regional Deep-Dive: Where are we now?
Chimwemwe Chamdimba
Principal Programme Officer-African Medicines Regulatory Harmonisation Program, African Union Development Agency-NEPAD, South Africa
New Continental IMS Working Group Africa – How is the system being set? How are learnings from other regions being utilised?
Sara Shatat
Head - General Administration of Innovative Products, Egyptian Drug Authority (EDA), Egypt
Update on ICH M4Q/R2
Fabio Bisordi, MSC
Global Head International Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
Regulatory Innovation: Strengthening collaboration through cloud-based platforms to accelerate medicines to patients
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