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Wednesday, June 29 • 10:30am - 11:30am
#314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-539-L04-P; CME 1.00; IACET 1.00; RN 1.00

A panel of experts will discuss novel approaches to developing and implementing a machine-readable protocol. Representatives from the clinical development, data standards, and regulatory affairs disciplines will review the impact of traceability.

Learning Objectives

Discuss the evolution of a protocol from a document to a digital platform; Describe an end-to-end traceability model from protocol to analysis; Describe the approach to automate reuse of protocol level information.

Chair

Robert A. DiCicco, PharmD

Speaker

Panelist
Eileen E. Navarro Almario

Panelist
Rebecca D. Kush, PhD

Panelist
Christine Pierre, RN



Chair
avatar for Robert DiCicco

Robert DiCicco

Vice President, Clinical Pharmacology Sciences and Operations, GlaxoSmithKline
Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over 25 years of experience in clinical development. His area of expertise includes clinical pharmacology and experimental medicine, clinical trial design, project... Read More →

Speakers
avatar for Eileen Navarro Almario

Eileen Navarro Almario

Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American College of Physicians and is board certified in Infectious Diseases. She has contributed to drug development guidances, therapeutic area standards development, PRO... Read More →
avatar for Rebecca Kush

Rebecca Kush

President and Chief Executive Officer, CDISC
Rebecca Daniels Kush, Ph.D. is a Founder and the President and CEO of the Clinical Data Interchange Standards Consortium (CDISC). Dr. Kush has worked for the NIH, academia, a global CRO and pharmaceutical companies in the U.S. and Japan. Dr. Kush earned a Ph.D. in Physiology and Pharmacology from the University of California (UCSD) School of Medicine in La Jolla, CA and has a B.S. in Chemistry and Biology from the University of New Mexico.
avatar for Christine Pierre

Christine Pierre

President, Society for Clinical Research Sites
Christine is an internationally recognized expert on the site landscape, trends and site management. She has conducted and contributed to research on site-related topics leading to meaningful change and stronger site partnerships and sustainability. She was the founder of RxTrials and is currently the President of the Society for Clinical Research Sites, a global trade organization representing over 2,800 sites in 42 countries and remains... Read More →


Wednesday June 29, 2016 10:30am - 11:30am
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA