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Hotel Holiday Inn

May 23, 2016 7:00 AM - May 25, 2016 5:00 PM

Haagse Schouwweg 10, 2332 KG Leiden, Netherlands

16th DIA Conference on European Electronic Data Management and eHealth Topics

The only conference focused on Electronic Content Management that brings together both regulatory agencies and industry to discuss how to reduce reliance on paper documents?

SESSION 8 - TRACK A & B - DOCUMENT AND DATA MANAGEMENT: THE REGULATORS/INSPECTORS VIEW OF THE FUTURE

Session Chair(s)

Klaus  Menges, DrMed

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

Telematics goes Global – How can Technology Strengthen Regulatory Systems?

Klaus Menges, DrMed

BfArM, Germany

Project Manager

Jason  Wakelin-Smith

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 and Head of Compliance Expert Circle

Georg  Neuwirther, MS, MSc

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

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