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Wednesday, June 30 • 4:00pm - 5:00pm
#357 SL: Risk-Based Quality Management and Monitoring: Practical Approaches

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-642-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session industry speakers will present their real-world experience with clinical trial oversight by discussing: 1) Case histories explaining audit and inspectional findings that identified significant compliance gaps, how findings were addressed, and proposals created to prevent similar findings in future studies, 2) Implementation of risk-based quality management and risk-based monitoring systems, 3) How the COVID-19 Pandemic has accelerated and transformed monitoring strategies, including use of centralized and remote monitoring strategies, and 4) Risk-based monitoring strategies used in a large COVID-19 Vaccine Trial and implications for successful implementation in future studies.

Learning Objectives

Identify the importance of risk-based quality management and risk-based monitoring systems in clinical trial oversight; Describe the importance of good corrective and preventive action planning and how it functions as an integral part of your risk-based quality management system; Discuss how the COVID-19 Pandemic has accelerated innovation and spurred the use of risk-based monitoring strategies, including centralized statistical monitoring and remote monitoring strategies.


Jean M. Mulinde, MD


Lessons Learned: Ensuring Electronic Systems Used in Clinical Trials Meet Data Integrity Requirements
Kelly Simpliciano, MS

Long-Term Site Monitoring Transformation Resulting from Critical Evaluation Brought About by COVID-19 Pandemic
Mary Arnould, BSN, MSN

Driving a Culture of Quality Through Risk-Based Monitoring on the Mega-COVID19 Vaccine Trial: A Case Study
Crupa Kurien

avatar for Mary Arnould

Mary Arnould

Director, Clinical Science Operations, Astellas, United States
Mary Arnould is Director, Center of Excellence & RBM Lead at Astellas Pharma and has been at Astellas over 3 years. She has over 25 years of clinical operations and site monitoring management experience, focusing on RBM implementation since 2014. Mary is currently leading RBM implementation... Read More →
avatar for Kelly Simpliciano

Kelly Simpliciano

Associate Director, Research Development Quality - Clinical Trials Systems & Aud, Bristol-Myers Squibb Company, United States
Kelly has worked in quality roles for clinical trials for 20 years, starting with computer system validation, and then moved into compliance and auditing. Kelly has experience performing audits of all types, including clinical investigator sites, vendors (i.e. CROs, imaging, IRT... Read More →
avatar for Crupa Kurien

Crupa Kurien

Central Monitoring Manager, Risk Based Monitoring, Data Monitoring & Management,, Pfizer Inc, United States
Crupa is an RBQM expert and served as a Central Monitor for the Landmark COVID19 Vaccine Trial at Pfizer. She now manages Pfizer's COVID19 Vaccine portfolio in the RBQM space.
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI, FDA, United States
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →

Wednesday June 30, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session