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Wednesday, June 17 • 2:00pm - 3:00pm
#333 SL: Driving Quality Through Innovative Approaches

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-726-L04-P; CME 1.00; IACET 1.00; RN 1.00

This potpourri of presentations by industry speakers will present new approaches to improve quality and compliance in clinical trials. Speakers will discuss: • How emerging digital technologies may transform industry’s approach to risk management, clinical trial oversight and auditing
• Deploying effective and efficient risk-based monitoring in clinical trials
• Challenges in identifying, classifying, tracking and analyzing protocol deviations and the toolkit developed by the Protocol Deviations Initiative to assist with protocol deviation management.

Learning Objectives

Discuss new technologies can be used to improve quality and compliance in clinical trials; Describe how risk-based monitoring impacts the conduct of clinical trials; Recognize why good protocol deviation identification, classification, tracking, and analysis methods are essential to maintaining quality in clinical trials.

Chair

Jean M. Mulinde, MD

Speaker

Modernizing R&D Quality and Compliance
Federico Feldstein, JD

Risk-Based Monitoring: An Examination of Probabilities and Rewards
MaryAnne Rizk, PhD

Solving Protocol Deviations Challenges: from Protocol Creation to CSR
Laura Galuchie



Speakers
avatar for Jean Mulinde

Jean Mulinde

Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA
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 →
avatar for Federico Feldstein

Federico Feldstein

Vice President, Head of R&D Quality Compliance, Johnson & Johnson
Federico Feldstein is Vice President, Head of R&D Quality & Compliance at Johnson & Johnson. Over the past 5 years, Federico has led the J&J R&D quality strategy leveraging the organizations’ strengths across the sectors (Medical Devices, Consumer, Pharmaceuticals) to enhance the... Read More →
avatar for Laura Galuchie

Laura Galuchie

Director, Global Clinical Trial Operations, Merck & Co., Inc. (MSD outside US and Canada)
Laura has a unique role which blends internal and external components. Externally, she is a member of TransCelerate BioPharma's Oversight Committee and has co-lead several workstreams. Internally, as the TransCelerate Program Lead, she has responsibility for driving engagement, and... Read More →
avatar for MaryAnne Rizk

MaryAnne Rizk

Senior Vice President, Digital R&D Strategy, IQVIA
Dr. Rizk has been a rising global digital technology lifescience executive for the past 20+ years, transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Effective in building enterprise alliance programs, She has forged clinical outsourcing... Read More →


Wednesday June 17, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Session