The 17th DIA Conference on European Electronic Document Management 2017 covers topics such as:
- 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
The 17th DIA Conference on European Electronic Document Management 2017 brings together:
- 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
