17th DIA Conference on European Electronic Document Management 2017

Topics

• Integrating eTMF and enterprise content/document management
• ETMF and content authoring
• ESubmission (eCTD 4.0) and portal
• Interoperability (e.g. eTMF with eTMF, eTMF with eDM, eTMF with data warehouse)
• Big data, data mining (signal detection) and data warehouses
• CTMS/Performance metrics
• Maintenance of XEVMPD and labelling management
• EDM and structured content management
• Interoperability and taxonomy/standardisation
• Preparing for IDMP
• Agency updates
• EHealth (eHR and Patient IDs)
• CRO Integration of processes
• Vendor panel discussion
• Integrating eDC, eDM, eSubmission and RIM (incl. XEVMPD and IDMPP)
• Outsourcing and Infrastructure
• Compliance tracking, analytics and management reporting
• Long term digital preservation of electronic content
• EISF and investigator portals

Who should Attend

• Agency representatives (e.g. inspectors and reviewers)
• Academic researchers
• CMC regulatory compliance specialists
• Clinical operations representatives
• Document and records managers
• CROs, CMOs and service providers
• Knowledge/IP professionals
• IT and support personnel
• Medical and technical writers
• Labelling specialists
• Quality assurance and compliance professionals
• Pharmacovigilance professionals
• Standards implementation specialists and associates
• Regulatory affairs/operations representatives
• Validation professionals