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The Future of Regulatory Affairs is Digital – Key Success Factors for Regulatory Affairs in a Rapidly Changing Environment
Session Chair(s)
Georg Neuwirther, MS, MSc
IT Director
Austrian Medicines & Medical Devices Agency (AGES), Austria
The “EU Telematics Strategy” describes a set of initiatives and goals which influence the business processes and techniques in our business. Nearly all processes are concerned by the implementation. New opportunities appear and challenges have to be mastered on the way to the digital future. This session will present an overview how NCAs (national competent authorities) and industry prepare.
Speaker(s)
The Digital Landscape Grows Fast and Triggers Opportunities and Challenges at the NCA Level - What Does this Mean for Business Processes and How Do NCAs Prepare?
Georg Neuwirther, MS, MSc
Austrian Medicines & Medical Devices Agency (AGES), Austria
IT Director
How Does Industry Prepare for the Digital Future Along the Value Chain?
Maren von Fritschen, PharmD
Moderna, Netherlands
Head EU Regulatory Policy
Opportunities and Challenges of ISO-IDMP Implementation
Kevin Horan
Health Products Regulatory Authority, Ireland
Director ICT and Business Services
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