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ELECTRONIC HEALTH RECORDS
Session Chair(s)
Gabriele Schwarz, MPharm
GCP Strategy Expert
Federal Institute for Drugs and Medical Devices (BfArM), Germany
This session is now a “pièce de résistance” at the EuroMeeting. This year we will again review and discuss new trends in GCP, quality management in clinical trials and pharmacovigilance. As in previous years thought leaders from regulatory authorities, industry and academia will share new trends in an interactive session
Speaker(s)
Regulatory Requirements for Electronic Health Records Used in Clinical Trials - a European inspector’s view
Christian Schoerner, PhD
Regierungspräsidium Darmstadt, Germany
Inspector
The Industry View: Are EHRs playing a role in making clinical trials more efficient?
Miguel Orri, MD
Innovatorri Pharma Consulting Ltd, United Kingdom
Managing Director
Compliance and Quality Requirements for EHRs in FDA-regulated clinical investigations
Sean Kassim, PhD
FDA, United States
Director, Office of Study Integrity and Surveillance, OTS, CDER
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