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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)
Telematics goes Global – How can Technology Strengthen Regulatory Systems?
Klaus Menges, DrMed
BfArM, Germany
Project Manager
Document and Data Management: The Regulators/Inspectors view of the future
Jason Wakelin-Smith
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Expert GCP Inspector & Head of Compliance Expert Circle
Global Standardization and Digital Collaboration: Will this Trend Affect NCAs Business and IT Processes Positively?
Georg Neuwirther, MS, MSC
Austrian Medicines & Medical Devices Agency (AGES), Austria
IT Director