戻る Agenda
ACHIEVING COMPLIANCE WITH ELECTRONIC SYSTEMS- THE REGULATOR’S PERSPECTIVE
Session Chair(s)
Gunnar Danielsson
Senior Regulatory Advisor
Pharma Consulting Group, Sweden
Ownership and control of electronic clinical trial data and documents is clearly defined in the regulations, whether it is the data (electronic data capture) or the documents (electronic investigator site file). However with the move to cloud-based systems, more and more sponsors are maintaining control of the systems, and therefore the access, meaning that the Investigators can no longer show their ownership. This extends from eSource to live trial systems to electronic archiving and is not in compliance to the Regulators requirements. In this session, the views and perspectives of FDA and EMA (via the Danish Health and Medicines Agency) will be provided.
Speaker(s)
Jonathan Solomon Helfgott, MS
Johns Hopkins University, United States
Senior Lecturer, Faculty, & Program Coordinator,
Philip Lange Moller
Danish Health and Medicines Authority, Denmark
GCP Inspector