FDA CERSI Lecture Series and CERSI Webinars
FDA's CERSI Lecture Series presents current research and advancements in regulatory science related to pre-clinical evaluation of safety and efficacy of medical products, emerging technologies, and assessing diverse data sets through information sciences to improve health outcomes.
Lectures are presented by scientists from the CERSI academic institutions or collaborators of CERSI investigators.
CERSI Webinars on FDA-relevant regulatory science topics are hosted by the CERSIs from their academic institutions.
Upcoming Events
- February 17, 2022: Distinguished Cybersecurity Speaker Series – What Biomedical Engineering Can Learn from Research and Academic Programs in Embedded Cybersecurity, University of California, San Francisco (UCSF)-Stanford CERSI
- May 19, 2022: Distinguished Cybersecurity Speaker Series – Security Engineering of Machine Learning, University of California, San Francisco (UCSF)-Stanford CERSI
Past Events
- December 16, 2021: Distinguished Cybersecurity Speaker Series - Laws for Cybersecurity? University of California, San Francisco (UCSF)-Stanford CERSI
- November 18, 2021: Distinguished Cybersecurity Speaker Series - Innocence and Experience: Regulatory Tales, University of California, San Francisco (UCSF)-Stanford CERSI
- November 9, 2021: Long COVID: risk factors, symptomology and patient reported outcomes captured through a novel digital platform, Yale Univ.-Mayo Clinic CERSI
- September 16, 2021: FDA CERSI Lecture on Outsourcing Facilities and Bulk Drug Substances: University of Maryland Research Projects by Dr. Ashlee Mattingly, University of Maryland CERSI
- June 9, 2021: Use of Online Data to Fortify Regulatory Science, Johns Hopkins University CERSI
- March 10, 2021: Precisely practicing medicine for COVID, from a half million tested patients and a trillion points of data, University of California, San Francisco (UCSF)-Stanford CERSI
- December 3, 2020: Cost Barriers to HIV PrEP Retention in Care in US Populations, Johns Hopkins University CERSI
- December 2, 2020: Patient Experience in Real World Settings: The CBER Science of Patient Input Program at the FDA, University of California, San Francisco (UCSF) – Stanford University CERSI
- November 4, 2020: Digital Health - Getting Ready for the Digital Future, University of California, San Francisco (UCSF) – Stanford University CERSI
- September 24, 2020: The Rise of Point of Care Manufacturing: The Mayo Clinic Experience, Yale University – Mayo Clinic CERSI
- June 2, 2020: Streamlining Genetic Safety Analysis for Ex Vivo Genome Edited Cell Therapies, University of California, San Francisco (UCSF) – Stanford University CERSI
- February 12, 2020: Tackling challenges of extracellular vesicle-based therapeutic development, University of Maryland CERSI
- November 6, 2019: The Role of Ontology and Controlled Terminology in Precision Medicine: Implications for Post-Market Surveillance, Johns Hopkins University CERSI
- 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
- June 11, 2019: TrialChain: A Blockchain-Based Platform to Validate Data Integrity in Large, Biomedical Research Studies, Yale University-Mayo Clinic CERSI
- March 19, 2019: Nondestructive Analytics for Biologics and Continuous Biomanufacturing, University of Maryland CERSI
- November 5,2018: Chan-Zuckerberg Biohub, University of California, San Francisco (UCSF) – Stanford University CERSI
- September 26, 2018: What Can Data Tell Us About the Opioid Crisis? Yale University-Mayo Clinic CERSI
- June 5, 2018: Non-invasive quantification of drug-target engagement at the tumor: Lessons from small molecules and biologics, Johns Hopkins University
- March 7, 2018: Near-infrared Fluorescence Imaging: A Tool for Enhancing Visualization of Biological Structures, University of Maryland CERSI
- January 25, 2018: Communication of Medication Information: Lessons Learned from Working with Uninsured Immigrants in Maryland, Georgetown University CERSI
- December 14, 2017: Patient-Centered Care - New Challenges in the Face of Chronic Conditions, Yale University-Mayo Clinic CERSI
- November 7, 2017: People and Their Data: Leveraging the Digital Transformation for a New Era of Knowledge Generation, Yale University-Mayo Clinic CERSI
- October 3, 2017: Systemic, Targeted Nanotherapies for Neurological Disorders: From Chemistry Towards Clinical Translation, Johns Hopkins University CERSI
- September 13, 2017: OneSource Checklists: Tools for Integrating Care and Research and Catalyzing a Sea Change in the Practice of Medicine, University of California, San Francisco-Stanford University CERSI
- June 26, 2017: Role and Relevance of Proton-Coupled Oligopeptide Transporters in the Brain, University of Maryland CERSI in Collaboration with CDER/OTS/OCP
- June 6, 2017: Sex Differences and Vascular Disease: Presentation, Diagnostics and Treatment, Georgetown University CERSI
- May 11, 2017: Reproducibility in Medicine and Science, University of California, San Francisco-Stanford University CERSI
- April 13, 2017: Zika Virus Vaccines and Therapeutics, University of Maryland CERSI
- March 22, 2017: Ensuring Accuracy in Clinical Trial Publications: Weighing Options, University of Maryland CERSI
- February 9, 2017: Neuroprosthetics and Brain Machine Interface: Innovation to Implementation, Johns Hopkins University CERSI
- January 19, 2017: Telemedicine: The Future of Clinical Trials, Georgetown University CERSI
- December 13, 2016: Leveraging Real-World Data and Shared Clinical Trial Data to Inform Regulatory Decision-Making, Yale University-Mayo Clinic CERSI
- December 8, 2016: Patient-Specific Stem Cells for Precision Medicine, University of California, San Francisco-Stanford University CERSI (Archived)
- November 30, 2016: DeepDive: A Data System for Macroscopic Science, University of California, San Francisco-Stanford University CERSI (Archived)
- October 26, 2016: A Molecular Stethoscope, University of California, San Francisco-Stanford University CERSI (Archived)
- September 20, 2016: Antibody-Targeted Cancer Immunotherapy, Georgetown University CERSI (Archived)
- May 18 & 25, 2021: Advancing COVID-19 Regulatory Science Using Clinical Informatics: A Two-Part Webinar, Johns Hopkins University CERSI Webinar
- March 28, 2018: Regulating Drugs on Efficacy Alone, The Drug Efficacy Study Initiative and its Economic and Therapeutic Legacies, Yale University-Mayo Clinic CERSI, Live Grand Rounds Webinar
- September 21, 2017: "Real World" Evidence: Beyond Randomized Controlled Trials, Yale University-Mayo Clinic CERSI, Live Webinar