News and Events
News
AUGUST 2019
CDRH Details Top Regulatory Science Priorities
JULY 2019
Sharpless Outlines FDA’s Key Priorities for Advancing Public Health
OCTOBER 2018
FDA Releases Medical Device Guidance for 2019
SEPTEMBER 2018
FDA Announces Compounding Research Projects
SEPTEMBER 2018
Putting the Brake on E-Cigarettes
JULY 2018
FDA Continues Taking Key Actions on Bulk Drug Substances Used for Compounding
APRIL 2018
FDA Goes All Out With Digital Health Regulatory Paradigm Shift
Upcoming Events
IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes
JH-CERSI, M-CERSI and FDA Collaborative Workshop
Virtual
January 26, 2022 - 10:30AM - 3:30PM
Official Event Page
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
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
Virtual
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.