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Session Chair(s)
Gabriele Schwarz, MPHARM
EC ICH E6(R3) Expert Working Group Member
Germany
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