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Cloud-based Submissions; from Principles to Practice
Session Chair(s)
Thomas Kühler, PHD, MSC
Head GRSP EU/AMEE
Sanofi R&D, France
The COVID-19 pandemic and evolving science have highlighted the need to improve the efficiency of regulatory processes. Here we will examine how collaborative innovative platforms and automation can improve contemporary regulatory decision making.
Learning Objective : The session will identify critical issues with the Dynamic Regulatory Assessment concept and propose answers to them while formulating and evaluating its merits and shortcomings. Governance and ownership models will be discussed and aspects of federated versus singular systems will be analyzed.
Speaker(s)
International Collaboration and Technical Aspects
Rodrigo Palacios, MBA
F. Hoffmann-La Roche Ltd., Switzerland
Senior Director, Technical Regulatory Policy
Dynamic Regulatory Assessment – the EFPIA View
Esteban Herrero-Martinez, PHD
Novartis Pharmaceuticals UK Limited, United Kingdom
Director Regulatory Policy and Intelligence
Drivers from a regulator’s perspective
Nikolai Constantin Brun, MD
Danish Medicines Agency, Denmark
Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics