Past Events
December 3, 2020
FDA CERSI Lecture Series
Cost Barriers to HIV pre-exposure prophylaxis (PrEP) Retention in Care in US Populations
Lorraine Dean, PhD
Associate Professor of Epidemiology, Johns Hopkins University
January 30, 2020
Johns Hopkins Student ISPE Lecture
FDA Center for Biologics Evaluation and Research (CBER) Real World Evidence Program
Hui-Lee Wong, PhD
CBER Sentinel Central Team, FDA CBER
November 6, 2019
FDA CERSI Lecture Series
The Role of Ontology and Controlled Terminology in Precision Medicine: Implications for Post-Market Surveillance
Christopher Chute, PhD
Deputy Director, Institute for Clinical and Translational Research, Johns Hopkins School of Medicine
March 20, 2019
Johns Hopkins Radiology In Vivo Cellular and Molecular Imaging Seminar Series
Targeting Tumor Specific Receptors for Cancer Therapy by Cancer Vaccines and Cellular Immunotherapy
Raj K. Puri, MD, PhD
Director, Division of Celluar & Gene Therapies, FDA CBER
November 28, 2018
Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities
JH-CERSI and FDA Collaborative Symposium
FDA White Oak Campus
October 3-4, 2018
Predictive Immunogenicity for Better Clinical Outcomes
JH-CERSI, M-CERSI and FDA Co-Sponsored Workshop
FDA White Oak Campus
June 5, 2018
FDA CERSI Lecture Series
Non-invasive Quantification of Drug-Target Engagement at the Tumor: Lessons from Small Molecules and Biologics
Sridhar Nimmagadda, PhD
Associate Professor of Radiology and Radiological Science
Johns Hopkins School of Medicine
December 7-8, 2017
Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation
CERSI-wide and FDA Collaborative Workshop
Tommy Douglas Conference Center (TDCC), Silver Spring, MD
Recordings of this workshop are now available here.
October 3, 2017
FDA CERSI Lecture Series
Systemic, Targeted Nanotherapies for Neurological Disorders: From Chemistry Towards Clinical Translation
Kannan Rangaramanujam, PhD
Arnall Patz Distinguished Professor of Ophthalmology
Co-Director, Center for Nanomedicine
Johns Hopkins School of Medicine
February 9, 2017
FDA CERSI Lecture Series
Neuroprosthetics and Brain Machine Interface: Innovation to Implementation
Nitish Thakor, PhD
Professor of Biomedical Engineering
Johns Hopkins University
The recording for this lecture is now available here.
February 2, 2017
FDA's Collection and Use of Patient Input in Regulatory Decision Making: Evaluation of Medical Devices
Michelle Tarver, MD, PhD
Medical Officer, FDA
JHSPH Wolfe St. Building, Room W2008
November 18, 2016
Substitutability of Generic Drugs: Perceptions and Reality
JH-CERSI and FDA Co-Sponsored Workshop
FDA White Oak Campus
Official Event Page
June 21, 2016
FDA CERSI Lecture Series
Measuring Harms that Matter to Patients in Clinical Trials
Evan Mayo-Wilson, DPhil
Assistant Scientist of Epidemiology
Johns Hopkins Bloomberg School of Public Health
January 15, 2016
'Safety, Value and Innovation' Seminar Series
Aaron Kesselheim, MD, JD, MPH
Professor of Medicine
Harvard School of Medicine, Brigham & Women's Hospital
December 2, 2015
Clinical Trials: Assessing Safety and Efficacy for a Diverse Population
JH-CERSI and FDA Co-Sponsored Workshop
FDA White Oak Campus
Official Event Page
May 4, 2015
'Safety, Value and Innovation' Seminar Series
M. Alan Brookhart, PhD
Associate Professor
Gillings School of Global Public Health, UNC-Chapel Hill
M-CERSI and FDA Co-Sponsored Workshop
Addressing Inadequate Information on Important Health Factors in
Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop
April 13, 2015
'Safety, Value and Innovation' Seminar Series
Caroline Popper, MD, MPH
Co-Founder and President
Popper and Company
March 30, 2015
'Safety, Value and Innovation' Seminar Series
Joshua Sharfstein, MD
Associate Dean
Johns Hopkins Bloomberg School of Public Health
January 26, 2015
'Safety, Value and Innovation' Seminar Series
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research,
Food and Drug Administration
January 12, 2015
Workshop on Missing Data in Randomized Clinical Trials
Daniel Scharfstein, PhD & Aidan McDermott, PhD
Supported, in part, by the FDA-JHU CERSI
October 2013
FDA Commissioner’s Lecture
Margaret Hamburg, MD
Commissioner of Food and Drugs