Two of our consultants recently represented KVALITO at the 15th DIA Conference on European Electronic Document Management, held on December 2-3 in Berlin, Germany. A wide range of interested parties attended the conference, from big pharma (Pfizer, Sanofi, Bristol-Meyers Squibb, GSK, Bayer, Novartis, Roche), health authorities (FDA, BfArM, Egyptian Ministry of Health, MHRA), providers and vendors, to hear new information about electronic document management in the area of clinical trials and pharmacovigilance.
Key topics that emerged from the conference presentations and discussions included:
Upcoming EU Clinical Trial Regulation:
Discussion and presentation about the upcoming clinical trial regulation and its impact on electronic document management for clinical trials. Intention of this regulation is to provide transparent overview about clinical trials inside the EU.
ISO, IDMP Standards:
The IDMP Standards provide standardized structures for the electronic transfer and storage of medicinal product information. This standard enables HCP to get easier access to the information which they are looking about a medicinal product.
How Business Contributes to Process Validation/Integration:
In this session the discussion was about what the different roles are for information governance and associated responsibilities. Also the generic workflow for the submission of required information to health authorities were mentioned as well as how complex systems can be implemented quickly.
Electronic Trial Master File challenges:
Presentation and discussion about the challenges for an eTMF, standardization, and implementation were topics in this session.
Regulatory Work and Business Models:
In this session it was discussed why standardized business models are necessary and how they can make the implementation of EDMS in pharmacovigilance and clinical area easier/efficient and align with day-to-day work.
End-to-End Digital Content Availability:
Presentation and discussion about virtual research organizations and how to align different vendors with the help of cloud-based eTMF and what this system should have in its scope.
Risk-Based Approach to Ensure Data Integrity:
Presentation from ACRES, which is an open global system for clinical research excellence and how to ensure data integrity in clinical trials.
Achieving Compliance with Electronic Systems – the Regulator’s Perspective:
Discussion about how cloud technology changes the regulatory perspective on electronic data from clinical trials and its management.
For more information about this conference please visit the conference website.