戻る Agenda
SESSION 6: Digital Transformation of the Regulatory Systems
Session Chair(s)
Geoffrey Williams
Director of Regulatory Information Management
Gilead Sciences, United Kingdom
Overview This Session aims to familiarise the audience with the cutting-edge developments in the digitalisation of regulatory submissions and global collaboration. As the pharmaceutical landscape rapidly evolves, understanding and adapting to new digital tools and harmonised standards is paramount for efficient development and patient access. We will delve into key initiatives transforming the regulatory ecosystem: the next generation of eCTD, ICH M4Q revision, Structured Product Quality Submissions, and ICH PQKM.
Speaker(s)
eCTD 4.0: Cornerstone for Digitalisation and Future Structured Product Quality Submissio
Hrishikesh Dhongade, MS
Novartis Healthcare Pvt. Ltd., India
Associate Director - Regulatory Affairs, Submission Standards and Strategy
ICH M4Q Update
Sara Shatat
Egyptian Drug Authority (EDA), Egypt
Head - General Administration of Innovative Products
ICH PQKM & Cloud-based Platforms
Hilmar Hamann, PhD
European Medicines Agency, Netherlands
Chief Information Officer
Artificial Intelligence Involvement in Regulatory Systems
Samya Alabdulrahim
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Senior Regulatory Affairs Expert
Panel Discussion with Q&A (With the additional participation of):
Panellist(s) Invited
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