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. The lectures are presented by scientists from the CERSI academic institutions or collaborators of CERSI investigators.
CERSI Webinars are hosted by the CERSIs from their academic institutions and discuss FDA-relevant regulatory science topics.
Upcoming Events
To be added
Past Events
- May 7, 2026: Synthetic Soup: Drug Supply and Overdose Trends
- May 4, 2026: The NAMolution of Regulatory Science Seminar Series
- April 3, 2026:The NAMolution of Regulatory Science Seminar Series
- March 12, 2026: Large Language Models for Interrogating Drug Labels/UCSF-CERSI
- March 2, 2026: The NAMolution of Regulatory Science Seminar Series
- January 27, 2026: Labeling for Transparency and Trust in AI/ML-enabled Cardiac Devices and Software: Patient and Clinician Needs Yale University/Mayo Clinic CERSI
- December 3, 2025: A Model-Informed Framework for Prioritizing Drug Studies in Pregnancy
- July 10, 2025: Clinical Trials Using Patient Health Data: Realities and Myths
- May 8, 2025: Large Language Models to Support Bioequivalence Evaluation University of California, San Francisco (UCSF) – Stanford University CERSI
- March 13, 2025: From Laboratories to Life: Using Regulatory Science to Advance Neural Interfaces for Sensorimotor Control
- January 21, 2025: Optimizing the Assessment of Cancer Treatment Tolerability: Examination of Patient-Reported Symptoms & Physical Function
- November 21, 2024: Penetration Testing of Medical Devices, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- November 14, 2024: Biomarkers and Therapeutics for Women's Cardiovascular Health, University of Maryland CERSI
- October 17, 2024: Protecting the Hospital Landscape against Ransomware Attacks and the Loss of Life, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- September 19, 2024: A Fireside Chat on Public-Private Partnerships for Healthcare Cybersecurity, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- July 23, 2024: Extracellular vesicles: a paradigm shift in gynecologic healthcare, University of Maryland CERSI
- May 16, 2024: Distinguished Cybersecurity Speaker Series – FDA Cybersecurity Focus Areas in 2024 and Beyond - What Should We Prepare For? University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- May 9, 2024: Improving the Diagnosis and Treatment of Women with Myocardial Ischemia and Non-obstructive Coronary Arteries, Yale University/Mayo Clinic CERSI
- April 18, 2024: Distinguished Cybersecurity Speaker Series – A Fireside Chat on Testing Like a Hacker, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- March 21, 2024: Distinguished Cybersecurity Speaker Series – A Fireside Chat on Strengthening the Cybersecurity of the Healthcare and Public Health Sector and Keeping Patients Safe, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- March 19, 2024: Vaccine outcomes to SARS-CoV-2 vaccine and variant viruses among pregnant people, Johns Hopkins University (JHU) CERSI
- February 15, 2024: Distinguished Cybersecurity Speaker Series – Overview of FDA’s Medical Device Cybersecurity Authorities and Program, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- January 23, 2024: Voices of Older Adults with Multiple Chronic Conditions and Their Perspectives on Clinical Trials, University of California, San Francisco (UCSF)-Stanford University CERSI
- November 16, 2023: A Fireside Chat on ARPA-H and DIGIHEALS, University of California, San Francisco (UCSF) – Stanford University CERSI
- November 9, 2023: READDI for the next pandemic, Research Triangle CERSI
- October 17, 2023: Prediction of Oral Drug Absorption and Biopharmaceutic Risk Using a Dissolution-Hollow Fiber Membrane (D-HFM) System, University of Maryland CERSI
- September 21, 2023: A Fireside Chat on FDA Updates on Medical Device Cybersecurity, University of California, San Francisco (UCSF) – Stanford University CERSI
- August 29-31, 2023: Dissolution and Translational Modeling Strategies for Physiologically Based Biopharmaceutics Modeling (PBBM), University Of Maryland CERSI
- July 25, 2023: Pediatric Medical Devices - Challenges and Opportunities, University of California, San Francisco (UCSF) – Stanford University CERSI
- May 18, 2023: Hacking to Healing: How Penetration Testing Improves Cyber Safety, University of California, San Francisco (UCSF)-Stanford CERSI
- May 23-24, 2023: Drug Dissolution in Oral Drug Absorption, University Of Maryland CERSI
- April 20, 2023: A Fireside Chat on Public and Private Collaboration in Healthcare Cybersecurity Preparedness, University of California, San Francisco (UCSF)-Stanford CERSI
- March 30, 2023: Understanding the Use of Existing Real-world Data for Medical Product Evaluation, Yale University – Mayo Clinic CERSI
- March 16, 2023: A Fireside Chat on FDA Updates on Medical Device Cybersecurity, University of California, San Francisco (UCSF)-Stanford CERSI
- March 7, 2023: Liquid Biopsies: Transformational Technologies to Enhance Translation from Bench to Bedside and Enable Precision Oncology by Valsamo Anagnostou, Johns Hopkins University CERSI
- February 16, 2023: A Fireside Chat on Lessons Learned After Two Decades of Medical Device Security Engineering, University of California, San Francisco (UCSF)-Stanford CERSI
- January 19, 2023: Cyber Risk and Impact to Patient Care: A Medical Device Imperative, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- December 15, 2022: Regulatory Affairs for Medical Device Security, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- November 17, 2022: Virtual Panel on Medical Device Security: Physician Perspectives from Cardiology, Neurosurgery, Emergency Medicine, and Anesthesiology, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- November 8, 2022: Maximizing Benefits and Minimizing Harms from Antibiotics: Scientific, Regulatory and Clinical Considerations by Dr. Sara Cosgrove, Johns Hopkins University CERSI
- September 15, 2022: Distinguished Cybersecurity Speaker Series - Security Engineering for Medical Products: Sensors, Signals, Semiconductors, Software Systems, University of California, San Francisco (UCSF)-Stanford CERSI
- September 13, 2022: Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations, Yale University – Mayo Clinic CERSI
- June 14, 2022: Airborne Respiratory Viral Infections and Non-Pharmaceutical Interventions, University Of Maryland CERSI
- May 19, 2022: Distinguished Cybersecurity Speaker Series – Security Engineering of Machine Learning, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- April 21, 2022: Distinguished Cybersecurity Speaker Series - Unringing the Bell: A Physician's Perspective on the Future Of Medical Device Security, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- March 17, 2022: Distinguished Cybersecurity Speaker Series - Modern Automotive Vulnerabilities: The Science Behind the Fast and the Furious, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- 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 Webinar
- January 20, 2022: Distinguished Cybersecurity Speaker Series – Security and Privacy for Humans, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- December 16, 2021: Distinguished Cybersecurity Speaker Series - Laws for Cybersecurity? University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- November 18, 2021: Distinguished Cybersecurity Speaker Series - Innocence and Experience: Regulatory Tales, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- 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
- May 18 & 25, 2021: Advancing COVID-19 Regulatory Science Using Clinical Informatics: A Two-Part Webinar, Johns Hopkins University CERSI Webinar
- 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
- September 13, 2019: CERSI Collaborative Research: Impacts on Advancing Public Health
- 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 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
- 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 21, 2017: "Real World" Evidence: Beyond Randomized Controlled Trials, Yale University-Mayo Clinic CERSI, Live Webinar
- 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)