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Putting It All Together: A Shared, Comprehensive, Integrated Global System for Clinical Research
Session Chair(s)
Greg Koski, MD, PhD
President and CEO, Co-Founder
Alliance For Clinical Research Excellence and Safety (ACRES), United States
This forum will discuss collaborative efforts to build a global system for clinical research to transform the clinical trials process. Addressing such topics as standards and accreditation for sites, a culture of safety, and a unified safety database, experts from key stakeholder groups (i.e., contract research organization, regulatory agency, pharmaceutical company, site, patient groups) will present their perspectives on the desirability, feasibility and challenges to the effort. We will finish with a dynamic, moderated interactive session with the audience and panelists.
Learning Objective : Describe what a global system for clinical research is including how it benefits the biomedical research endeavor; Explain how a global system would work in practice and give examples; Identify the challenges to the development and implementation of a global system, with a focus on steps needed to resolve any problems.
Speaker(s)
Panelist
Daniel O'Connor, JD
InnovoCommerce, United States
Chief Business Officer
Panelist
Debra Lappin, JD
FaegreBD Consulting, United States
Head, Health Biosciences Practice
Panelist
Kimberly Irvine
BRANY, United States
Executive Vice President, COO
Panelist
Richard Moscicki, MD
PhRMA, United States
Chief Medical Officer and Executive Vice President, Science and Regulatory