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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)
Hrishikesh Dhongade, MS
Associate Director - Regulatory Affairs, Submission Standards and Strategy, Novartis Healthcare Pvt. Ltd., India
eCTD 4.0: Cornerstone for Digitalisation and Future Structured Product Quality Submissio
Sara Shatat
Head - General Administration of Innovative Products, Egyptian Drug Authority (EDA), Egypt
ICH M4Q Update
Hilmar Hamann, PHD
Chief Information Officer, European Medicines Agency, Netherlands
ICH PQKM & Cloud-based Platforms
Samya Alabdulrahim
Senior Regulatory Affairs Expert, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Artificial Intelligence Involvement in Regulatory Systems
Panellist(s) Invited
, Qatar
Panel Discussion with Q&A (With the additional participation of):
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