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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

Official Event Page

 

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

Official Event Page

 

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

Official Event Page

 

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