DIA
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INNOVATIVE METHODOLOGIES USED IN ENHANCING QUALITY

Track:
Innovation in Clinical Research

Day & Time:
March 27, 9:00AM - 10:30AM (Central European Standard Time)

Session Number:
0605

Room Number:
F1

Type:
Session

Title:
INNOVATIVE METHODOLOGIES USED IN ENHANCING QUALITY

Chair(s):
Sherri A. Hubby
Director, US Quality Assurance
Premier Research Group, United States

Description:
In this session, the speakers focus on specific novel methodologies which improve quality to improve three aspects of drug development which prove always to be challenging.

Presentation(s) & Speaker(s):
Use of Virtual Population Simulation to Improve Protocol Design and Amendment Management
Badri Rengarajan, DrMed
VP Medical Affairs (most recently)
Consultant, United States

Pharma must learn how to develop a risk-based monitoring system as an adjunct to other risk management tools throughout the monitoring lifecycle to ensure quality, data integrity and the protection of the patient.
Sherri A. Hubby
Director, US Quality Assurance
Premier Research Group, United States

Identifying Patients at Risk in Clinical Trials Using data Mining and Data Visualisation Technologies
Robbert P. Van Manen, MSc
Master Principal Solutions Consultant
Oracle Health Sciences, Netherlands