Pediatric Clinical Investigator Training Course: 2019

Below are slides from the Clinical Investigator Training Course held on February 28, 2019, in Silver Spring, Maryland.
 

To be alerted when registration for the 2020 course opens, please email clinicalinvestigator@fda.hhs.gov.

The audio recordings from this event are now available online via Adobe Connect:

Part 1      Part 2      Part 3      Part 4

Download the Agenda (PDF)

 

Welcome and Introduction
 

Susan McCune, M.D.

Slides

Keynote Speaker and Setting the Stage

Bridgette Jones, M.D.
American Academy of Pediatrics (AAP)

Slides

Label Enabling Clinical Trials

William Smoyer, M.D.
Nationwide Children's Hospital

Slides

 

Hot Topics

 

Extrapolation and Innovative Trial Designs

Yodit Belew, M.D.
Division of Antiviral Products
Food and Drug Administration


Slides

Molecular Targets -- Oncology

Greg Reaman, M.D.
Office of Hematology and Oncology Products
Food and Drug Administration

Slides

Enrolling Pediatric Patients in Adult Trials

Tara Altepeter, M.D.
Division of Gastroenterology and Inborn Error Products
Food and Drug Administration


Slides
 

 

Break

 

 

The Basics
(New Investigators)

 

Opening an IND

Michael Cohen-Wolkowiez, M.D.
Pediatric Trials Network

Slides

FDA Perspective of Study Design and Plan, Dose Selection

 John Alexander, M.D.
Division of Pediatric and Maternal Health
Food and Drug Administration

Slides

Ethical Considerations

Melanie Bhatnagar, M.D.
Food and Drug Administration

Slides

Pediatric Formulations

Julia Pinto, Ph.D.
Food and Drug Administration

Slides

Non-clinical Data Requirements

 Karen Davis-Bruno, Ph.D.
Food and Drug Administration

Slides

Good Clinical Practice and Understanding the Regulations
Susan Leibenhaut, M.D.
Food and Drug Administration

Slides

Safety Considerations: Regulatory Definitions and Practical Considerations
Ramy Abdelrahman, M.D.
Food and Drug Administration

Slides

Discussion/Case Presentation

Michael Cohen-Wolkowiez, M.D.
Pediatric Trials Network
 
Jonathan Davis, M.D.
Tufts Medical Center

Cohen-Wolkowiez Slides

Davis Slides

 
Lunch

 

Pediatric Trial Funding and Engagement Panel Discussion

Rohan Hazra, M.D. (NIH/NICHD)

Jonathan Davis, M.D. (Clinical and Translational Science Awards)

Michael Cohen-Wolkowiez, M.D. (Duke University)

Ed Connor, M.D. (Institute for Advance Clinical Trials for Children)

Bridgette Jones, M.D. (AAP)

Steven Hirschfeld, M.D., Ph.D. (NIH/NIDCD)

Hazra Slides

Davis Slides

Cohen-Wolkowiez Slides

Connor Slides

Jones Slides

Hirschfeld Slides

 

Practical Applications with Case Studies

Moderator: Lynne Yao, M.D.

 

Table Moderators

Susan McCune, M.D.

Lily Mulugeta, Pharm.D.

Kevin Krudys, Ph.D.

Shirley Seo, Ph.D.

Yodit Belew, Ph.D.

Tara Altepeter, M.D.

  

 

Break

 

 


General Questions and Answers

Full Panel with Dr. Lynne Yao (Moderator)

 

 

 


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