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Center of Excellence in Regulatory Science and Innovation

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Upcoming Events


FDA-CERSI Collaborative Workshops and Training

A list of upcoming CERSI workshops co-sponsored by FDA and CERSI academic institutions, or held by those individual universities, is on the FDA ORSI website here


Recent Events


Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation

FDA Office of Women's Health (OWH) and JH-CERSI Collaborative Workshop
May 9, 2022 - 10:00AM - 2:30PM (Virtual)
Official Event Page

Event Recording


IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes

JH-CERSI, M-CERSI and FDA Collaborative Workshop
January 26, 2022 - 10:30AM - 3:30PM
Official Event Page


Use of Online Data to Fortify Regulatory Science 

FDA CERSI Lecture Series
Mark Dredze, PhD
John C. Malone Associate Professor of Computer Science
Johns Hopkins University
June 9, 2021 - 3:00-4:00PM
Official Event Page


Advancing COVID-19 Regulatory Science Using Clinical Informatics: A Two-Part Webinar

JH-CERSI and FDA Collaborative Webinar
May 18, 2021 - 12:00 - 1:30PM
May 25, 2021 - 12:00 - 1:30PM

Official Event Page


Cost Barriers to HIV pre-exposure prophylaxis (PrEP) Retention in Care in US Populations

FDA CERSI Lecture Series
Lorraine Dean, PhD
Associate Professor of Epidemiology
Johns Hopkins University
December 3, 2020 - 3:00-4:00PM
Official Event Page


FDA Center for Biologics Evaluation and Research (CBER) Real World Evidence Program

Johns Hopkins Student ISPE Lecture
Hui-Lee Wong, PhD
CBER Sentinel Central Team, FDA CBER
January 30, 2020- 12:15 - 1:30PM


The Role of Ontology and Controlled Terminology in Precision Medicine: Implications for Post-Market Surveillance

FDA CERSI Lecture Series
Christopher Chute, PhD
Deputy Director, Institute for Clinical and Translational Research
Johns Hopkins University, Johns Hopkins School of Medicine
November 6, 2019 - 3:00-4:00PM
Official Event Page


Targeting Tumor Specific Receptors for Cancer Therapy by Cancer Vaccines and Cellular Immunotherapy

Johns Hopkins Radiology In Vivo Cellular and Molecular Imaging Seminar Series
Raj K. Puri, MD, PhD
Director, Divison of Cellular & Gene Therapies, FDA CBER
March 20, 2019 - 3:30 - 4:30PM


Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities

JH-CERSI and FDA Collaborative Symposium
FDA White Oak Campus
November 28, 2018 - 8:15AM - 4:30PM
Official Event Page


For information on future FDA CERSI Lecture Series seminars, please visit the official webpage.