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  1. Advancing Regulatory Science

2019 FDA CERSI Lecture Series

March 19, 2019

Nondestructive Analytics for Biologics and Continuous Biomanufacturing,
University of Maryland CERSI

Bruce Yu, Ph.D
Professor, Pharmaceutical Sciences
Director, Bio- and Nano-Technology Center
University of Maryland School of Pharmacy

For more information, click here.


June 11, 2019

TrialChain: Blockchain-Based Platform for Validation of Data Integrity of Large, Biomedical Research Studies,
Yale University-Mayo Clinic CERSI

Wade Schulz, MD, PhD
Assistant Professor and Director of Informatics
Department of Laboratory Medicine
Center for Outcomes Research & Evaluation (CORE)
Yale School of Medicine
 

For more information, click here.


October 2, 2019
Advances in Patient Preference Information to Enhance Benefit-Risk Assessment: Learning from Case Studies
University of California, San Francisco (UCSF) – Stanford University CERSI

Leslie Wilson, PhD
Professor of Health Policy and Economics
Departments of Medicine and Clinical Pharmacy
University of California, San Francisco (UCSF)

For more Information, click here.


November 6, 2019
The Role of Ontology and Controlled Terminology in Precision Medicine: Implications for Post-Market Surveillance
Johns Hopkins University CERSI

Christopher Chute, MD, DrPH
Bloomberg Distinguished Professor of Health Informatics
Professor of Medicine, Public Health, and Nursing
Chief Research Information Officer, Johns Hopkins Medicine
Deputy Director, Institute for Clinical and Translational Research
Johns Hopkins University

For more Information, click here.