CDER Town Hall: Part 1 of 2

Track:
Global Regulatory

Day & Time:
June 27, 9:00AM - 10:30AM

Session Number:
417

Room Number:
210B

Level:
Basic

Type:
Forum

Title:
CDER Town Hall: Part 1 of 2

Chair(s):
Nancy D. Smith, PhD
Adjunct Professor at Temple University
FDA Alumni Association, United States

Description:
This forum is a roundtable discussion with CDER leadership. Topics to be discussed will depend on the interests of the audience. Panel members will discuss and update regulatory changes and the current hot topics at CDER.

Part 2 of this forum will take place Thursday, June 27 at 10:45 am

Learning Objective(s):
Summarize key issues discussed by CDER management; Identify regulatory hot topics in drug development and regulation.

Presentation(s) & Speaker(s):
Panelist
Gerald J. Dal Pan, MD
Director, Office of Surveillance and Epidemiology, CDER
FDA, United States

Panelist
John K. Jenkins, MD
Director, Office of New Drugs, CDER
FDA, United States

Panelist
Justina A. Molzon, JD,MPharm
Associate Center Director for International Programs, CDER
FDA, United States

Panelist
Robert T. O'Neill, PhD
Senior Statistical Advisor, Office of Translational Sciences, CDER
FDA, United States

Panelist
Robert J. Temple, MD
Deputy Center Director for Clinical Science, CDER
FDA, United States