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SESSION 8 - TRACK A & B - DOCUMENT AND DATA MANAGEMENT: THE REGULATORS/INSPECTORS VIEW OF THE FUTURE
Session Chair(s)
Klaus Menges, DrMed
Project Manager, BfArM, Germany
The future of document and data management in a regulatory environment is clearly influenced by the Regulators themselves, the type of data and documents that they need to manage for their own business and what they expect to see when a company is inspected or required to provide for compliance purposes. This session will provide an opportunity to hear directly from Regulators and Inspector regarding how they see the future for document and data management.
Speaker(s)
Klaus Menges, DrMed
Project Manager, BfArM, Germany
Telematics goes Global – How can Technology Strengthen Regulatory Systems?
Jason Wakelin-Smith
Expert GCP Inspector & Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Document and Data Management: The Regulators/Inspectors view of the future
Georg Neuwirther, MS, MSC
IT Director, Austrian Medicines & Medical Devices Agency (AGES), Austria
Global Standardization and Digital Collaboration: Will this Trend Affect NCAs Business and IT Processes Positively?
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