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?

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SESSION 3 - TRACK B - ARCHIVING

Session Chair(s)

Eldin Rammell

Head of Quality Assurance

Phlexglobal Ltd, United Kingdom

The publication of Regulation 536/2014 confirmed a minimum retention time of 25 years for clinical trial documents in the EU. In a digital age, preserving the authenticity and reliability of records for these periods of time – and longer- can be a challenge. This session will review the regulatory requirements, the technology landscape and options, and business strategies to ensure long-term access to archived records.

Speaker(s)

We Have to Keep the TMF for How Long? What the Regulations Really Say about Archiving

Eldin Rammell

Phlexglobal Ltd, United Kingdom

Head of Quality Assurance

Keep Calm…. and do Practical Record Preservation

Matthew Addis, PhD

Arkivum Ltd, United Kingdom

CTO

Business Concepts to Master Challenges of Electronic Document Preservation – A Case Study

Jens Kerim Ergueden

Bayer AG, Germany

Head, Document Management Wuppertal

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

SESSION 3 - TRACK B - ARCHIVING

Session Chair(s)

Eldin Rammell

Speaker(s)

We Have to Keep the TMF for How Long? What the Regulations Really Say about Archiving

Keep Calm…. and do Practical Record Preservation

Business Concepts to Master Challenges of Electronic Document Preservation – A Case Study

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