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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
Sara Shatat
Head - General Administration of Innovative Products, Egyptian Drug Authority (EDA), Egypt
Hilmar Hamann, PHD
Chief Information Officer, European Medicines Agency, Netherlands
Samya Alabdulrahim
Senior Regulatory Affairs Expert, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Panellist(s) Invited
, Qatar
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