PCG participates with chairman and presenter in the one day seminar arranged in collaboration with the Section for Clinical Trials, a part of the Swedish Pharmaceutical Society, and Medical Products Agency.
Date: 2015-09-22
The Swedish Academy of Pharmaceutical Sciences has collected a panel of international experts from the British (MHRA), Danish (DHMA), and Swedish (MPA) regulatory agencies as well as from industry, vendors and academia. They will present current thinking on the use of electronic systems for Data Capture (EDC), Case Report Forms (eCRF), Patient Reported Outcomes (ePRO), Trial Master Files (eTMF) and data from Electronic Health Records (EHRs), as well as inspection findings that can be attributed to the use of such systems. The use and pitfalls of electronic systems will be presented from the point of view of both pharmaceutical industry, CRO and clinical site.
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